    [Senate Hearing 116-259]
    [From the U.S. Government Publishing Office]

                                                            S. Hrg. 116-259

             BIOLOGICAL THREATS TO UNITED STATES NATIONAL SECURITY

    =======================================================================

                                    HEARING

                                   before the

                                SUBCOMMITTEE ON
                       EMERGING THREATS AND CAPABILITIES

                                     of the

                          COMMITTEE ON ARMED SERVICES
                              UNITED STATES SENATE

                         ONE HUNDRED SIXTEENTH CONGRESS

                                 FIRST SESSION

                                   __________

                               NOVEMBER 20, 2019

                                   __________

             Printed for the use of the Committee on Armed Services

    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                      Available via http://www.govinfo.gov

                               ______

                   U.S. GOVERNMENT PUBLISHING OFFICE
    41-309 PDF             WASHINGTON : 2020

                          COMMITTEE ON ARMED SERVICES

                         JAMES M. INHOFE, Oklahoma,
                                 Chairman

    ROGER F. WICKER, Mississippi      JACK REED, Rhode Island
    DEB FISCHER, Nebraska             JEANNE SHAHEEN, New Hampshire
    TOM COTTON, Arkansas              KIRSTEN E. GILLIBRAND, New York
    MIKE ROUNDS, South Dakota         RICHARD BLUMENTHAL, Connecticut
    JONI ERNST, Iowa                  MAZIE K. HIRONO, Hawaii
    THOM TILLIS, North Carolina       TIM KAINE, Virginia
    DAN SULLIVAN, Alaska              ANGUS S. KING, Jr., Maine
    DAVID PERDUE, Georgia             MARTIN HEINRICH, New Mexico
    KEVIN CRAMER, North Dakota        ELIZABETH WARREN, Massachusetts
    MARTHA McSALLY, Arizona           GARY C. PETERS, Michigan
    RICK SCOTT, Florida               JOE MANCHIN, West Virginia
    MARSHA BLACKBURN, Tennessee       TAMMY DUCKWORTH, Illinois
    JOSH HAWLEY, Missouri             DOUG JONES, Alabama

                           John Bonsell, Staff Director
                        Elizabeth L. King, Minority Staff
                                     Director

               Subcommittee on Emerging Threats and Capabilities

                          JONI ERNST, Iowa, Chairman

    DEB FISCHER, Nebraska                GARY C. PETERS, Michigan
    KEVIN CRAMER, North Dakota           JEANNE SHAHEEN, New Hampshire
    MARSHA BLACKBURN, Tennessee          MARTIN HEINRICH, New Mexico
    JOSH HAWLEY, Missouri                MAZIE K. HIRONO, Hawaii

                                      (ii)

                             C O N T E N T S

                               November 20, 2019

                                                                       Page

    Biological Threats to United States National Security............     1

    Inglesby, Dr. Thomas V., Director, Center for Health Security,        3
      Johns Hopkins Bloomberg School of Public Health.
    Dr. Julie L. Gerberding, Co-Chair, Commission on Strengthening       10
      America's Health Security, Center for Strategic and
      International Studies.
    O'Toole, Dr. Tara J., Senior Fellow and Executive Vice President,    16
      In-Q-Tel.

    Appendix A.......................................................    35

                                     (iii)

             BIOLOGICAL THREATS TO UNITED STATES NATIONAL SECURITY

                                  ----------

                          WEDNESDAY, NOVEMBER 20, 2019

                               U.S. Senate,
                                Subcommittee on
                     Emerging Threats and Capabilities,
                                   Committee on Armed Services,
                                                        Washington, DC.
        The subcommittee met, pursuant to notice, at 3:04 p.m. in
    Room SR-222, Russell Senate Office Building, Senator Joni Ernst
    (chairman of the subcommittee) presiding.
        Subcommittee Members present: Senators Ernst, Fischer,
    Hawley, and Peters.

                OPENING STATEMENT OF SENATOR JONI ERNST

        Senator Ernst. Good afternoon, everyone. I want to thank
    you all for joining us today.
        The Emerging Threats and Capabilities Subcommittee meets
    today to receive testimony from Dr. Julie Gerberding, Co-Chair
    of the Center for Strategic and International Studies' (CSIS)
    Commission on Strengthening America's Health Security; Dr.
    Thomas V. Inglesby, Director at the Center for Health Security
    at Johns Hopkins Bloomberg School of Public Health; and Dr.
    Tara J. O'Toole, Senior Fellow and Executive Vice President at
    In-Q-Tel.
        Our focus today will be to gain a deeper understanding of
    the nature and severity of biological threats to our national
    security, as well as the preparedness of the United States to
    defend against and respond to these threats.
        I thank our witnesses for being with us today.
        The 2018 National Biodefense Strategy identified biological
    threats, whether naturally occurring, accidental, or deliberate
    in origin, as among the most serious threats facing the United
    States and the international community and capable of causing
    catastrophic harm to the United States.
        Despite the severity of this threat, I note that a recent
    report by the Center for Strategic and International Studies'
    Commission on Strengthening America's Health Security states
    that the United States remains woefully ill-prepared to respond
    to global health security threats. I find this deeply
    concerning, given the potential devastation of a biological
    event, and look to our witnesses to provide their candid
    assessment of the U.S. posture and programs focused on dealing
    with this challenge.
        Of particular interest is the role of the Department of
    Defense (DOD) in providing sufficient biodefense both abroad
    and at home. DOD has had many biosecurity successes such as
    securing laboratories in allied countries, providing
    surveillance of especially dangerous pathogens, and developing
    lifesaving vaccines for our warfighters. While this
    subcommittee is principally focused on the Department of
    Defense's role in countering the threat, this does not stop at
    a vaccine. It requires constant research, investment, and
    planning across federal, State, and local governments.
        While advancements in biotech research and development have
    provided innovative solutions for treating disease, developing
    alternative fuels, and promoting food security, they have also
    generated new security risks. For example, gene editing
    technology, new targeting methods, and vaccine-resistant
    disease could all be used for nefarious purposes by state and
    non-state actors alike.
        Another particular area of concern for me in my home State
    of Iowa is the potential impact of a biological incident in the
    agricultural sector. A biological attack targeting specific
    types of crops or livestock could be devastating to Iowa
    farmers and have a severely negative impact on the Iowa
    economy. Such an event would not only impact Iowans. Indeed,
    folks across the country would potentially feel the effects of
    food shortages, and the American economy as a whole would
    suffer if our agricultural industry was to be the target of
    such an attack.
        Again, I thank our distinguished witnesses for being with
    us, and I look forward to their testimony.
        I will now turn it over to our ranking member, Senator
    Peters, for his opening statement.

                    STATEMENT OF SENATOR GARY PETERS

        Senator Peters. Well, thank you, Chairman Ernst for holding
    this very important hearing here today.
        I want to thank each of our witnesses for taking time to
    come before us and present your thoughts, as well as answer our
    questions.
        There is no question that the threats that we face in the
    area of biosecurity are vast, they are complex and evolving.
    Adversarial nation states still retain the capability to
    produce biological weapons in spite of the Biological Weapons
    Convention. Now even non-state terrorist groups like ISIS
    [Islamic State of Iraq and Syria] can recruit technically
    trained scientists to weaponize pathogens as instruments of
    terror.
        We are in the midst of a technological revolution in gene
    editing with CRISPR [Clustered Regularly Interspaced Short
    Palindromic Repeats], which will give scientists an
    unprecedented ability to modify the genetic code.
        Finally, we must safeguard against threats to our
    agriculture and food supply, such as the African swine fever
    that is spreading at a very rapid pace through Asia and Europe.
        In recent years, Congress has worked to address these
    serious threats. The 2017 National Defense Authorization Act
    required the President to develop a comprehensive biosecurity
    to recognize the spectrum of threats that we face from natural
    occurring outbreak of Ebola to its use by ISIS.
        Published in October of 2018, the Strategy is the first
    acknowledgement of the continuum of threats that we now face.
    Dangerous pathogens know no international borders, and a public
    health biosecurity incident is just as dangerous as an attack
    by a bioweapon.
        More importantly, the Strategy coordinates efforts across
    the Federal Government to better detect and prevent and, if
    necessary, respond to a biothreat.
        While we have made significant progress in the area, we
    still face a number of gaps in our country's biological
    defenses. The bipartisan Commission on Biodefense identified
    numerous recommendations to strengthen those defenses and
    protect our country from the vast array of biological threats.
        The Department of Defense plays a key role in supporting
    the biosecurity strategy, and I look forward to exploring the
    Department's contribution and hearing today about how we can
    improve those efforts.
        Once again, thank you for your testimony here today. I look
    forward to it a great deal.
        Senator Ernst. Now we will go ahead, and we will do our
    witness testimony. Dr. Inglesby, if you would go ahead and
    start. We will have about 5 minutes for your statement. Thank
    you.

       STATEMENT OF DR. THOMAS V. INGLESBY, DIRECTOR, CENTER FOR
       HEALTH SECURITY, JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC
                                 HEALTH

        Dr. Inglesby. Thank you. chairman Ernst, Ranking Member
    Peters, and members of the committee, thank you for the chance
    to speak with you today.
        My name is Tom Inglesby. I am the Director of the Center
    for Health Security at Johns Hopkins and a professor of public
    health and medicine at Johns Hopkins University.
        The country faces a range of biological threats that could
    emerge without warning, whether from nature, deliberate attack,
    or accident. These threats could include a global pandemic of
    avian influenza, lethal emerging infectious diseases spreading
    from person to person, bioweapons threats like smallpox or
    anthrax, or newly engineered biological threats. Epidemics
    could be caused by accidents from labs working with viruses
    like smallpox or SARS [Severe Acute Respiratory Syndrome] or
    MERS [Middle East Respiratory Syndrome], which are no longer
    circulating in the world, or from research aimed at creating
    novel potential pandemic strains of pathogens. The country also
    faces the potential for deadly large-scale animal outbreaks or
    plant epidemics that kill important crops.
        In major human epidemics, there would likely be an urgent
    need for medicines and vaccines and ventilators, possible
    pressure to close borders, and the potential for hospitals to
    collapse under pressure. There could be serious impact on
    national security and to the Department of Defense with risks
    to health and life in the force and their families, a surge in
    need for medical supplies, big challenges to deployments,
    interruptions to logistics lines, and economic shocks, and
    other disruptions to the country.
        The 2018 National Biodefense Strategy sets national
    priorities for addressing this range of biological threats, and
    this is forward progress. But now the challenge will be
    implementation across the government. I have described a few of
    DOD's important biodefense programs in written testimony. A few
    brief words about them here.
        The Joint Program Executive Office for Chem Bio
    Preparedness works to accelerate the development of new medical
    countermeasures. DARPA's [Defense Advanced Research Projects
    Agency] Bio Technologies Office runs programs seeking
    disruptive change in biotechnology, including new ways to
    manufacture critical molecules and building safety into the
    work of biological science. The Biological Threat Reduction
    program is helping build safe, secure labs in parts of the
    world where new outbreaks could emerge with efforts in 29
    countries. I think all of these programs should be supported.
        Here are my other recommendations to you. The DOD, together
    with HHS [United States Department of Health and Human
    Services] BARDA [Biomedical Advanced Research and Development
    Authority] should substantially increase efforts aimed at
    accelerating vaccine and medicine development for new threats.
    This will require strong programs in government working in
    close partnership with biopharma.
        DOD planning assumptions for pandemics should anticipate
    great disruption to decision-making and operations. The recent
    Clade X and Event 201 exercises showed how pandemics could
    affect national decision-making around travel and trade, the
    use of medical and scientific assets overseas, troop
    deployments, civil liberties around quarantine, and the
    national and international allocation of scarce supplies of
    vaccine.
        The U.S. Government should reestablish a biological threat
    assessment process, which used to be in place. It should
    include not only a focus on bioterrorism, but on state programs
    as well, as well as the possibility of omnicidal or apocalyptic
    groups seeking biological weapons.
        The U.S. Government should plan for the possibility of
    global catastrophic biological risks. These are events that
    could lead to sudden widespread disaster beyond the capability
    of national governments and the private sector to control with
    potential for great loss of life and disruption of governments,
    economies, and global security.
        I would urge you to strongly support the Biological Weapons
    Convention. It is a critical international norm against the
    development and use of biological weapons.
        We should strengthen the U.S. agricultural biodefense
    planning and programs. The USDA [United States Department of
    Agriculture] has made substantial progress in recent years
    around strengthening its programs, but there are priorities
    that should be addressed, including stronger crop surveillance,
    animal wildlife surveillance, more support for animal vaccine
    development, and more funding for agriculture biodefense
    overall.
        We should increase planning with the private sector on
    biothreat initiatives. The private sector is the maker of
    vaccines and medicines and diagnostics. It is also the key
    driver in maintaining travel and trade in major epidemics and
    in supply chain management, communication channels, and many
    more essential missions.
        Finally, we should focus on strengthening the U.S.
    bioeconomy, which underlies a lot of this. That includes
    medicines and vaccines, food production, energy production, and
    industrial processes. The success of the bioeconomy is
    important to national security just as in the way that U.S.
    manufacturing in Silicon Valley have been to U.S. national
    security as well.
        In conclusion, there are a range of serious biological
    threats facing the country. It is critical that DOD continue to
    invest in and prepare for biological threats, particularly high
    consequence threats, even catastrophic ones, that could have
    major national security implications.
        Thank you.
        [The prepared statement of Dr. Inglesby follows:]

                     Prepared Statement by Tom Inglesby, MD
        Chairman Ernst, Ranking Member Peters, and members of the
    Committee, thank you for the chance to speak with you today about
    Biological Threats to U.S. National Security.
        My name is Tom Inglesby. I am the Director of the Center for Health
    Security of the Johns Hopkins Bloomberg School of Public Health and a
    Professor of Public Health and jointly in Medicine at Johns Hopkins
    University. The opinions expressed herein are my own and do not
    necessarily reflect the views of The Johns Hopkins University.
        Our Center's mission is to protect people's health from major
    epidemics and disasters and build resilience. We study the
    organizations, systems, and tools needed to prepare and respond.
        I will provide comments on biological threats facing the country,
    major drivers of those threats, and key Department of Defense programs
    which are aimed at preparing for and responding to them. My testimony
    will also provide strategic recommendations about how the DOD, in
    concert with other departments and agencies should be considering and
    acting to prevent and prepare to respond to these threats.
    Biological Threats to the United States
        The country faces a range of biological threats that can emerge
    without warning from nature, deliberate attack, or accidental release.
    We have had major influenza pandemics in the past and there is
    scientific agreement we will again experience a pandemic of influenza
    that sweeps the world, including the U.S. There will likely also be the
    emergence of new infectious diseases spread by respiratory route from
    person to person, such as the SARS or MERS viruses which emerged as
    surprises and had case fatality rates of 10 percent and 30 percent,
    respectively.
        In terms of deliberate threats, we continue to face the prospect of
    biological weapons attacks, both from known very high consequence
    pathogens, such as the agents that cause anthrax and smallpox, as well
    as from unknown novel and engineered biological threats. Epidemics
    could also emanate from pathogens that are released from research labs
    accidentally, including from laboratories working on non-circulating
    viruses such as SARS or smallpox, or from research work that has
    created novel epidemic strains of pathogens. We have seen biosafety
    breaches in our own DOD and CDC labs in the past, and accidents in
    other labs internationally. In the realm of animals and plants, we
    could also face high consequence natural, deliberate or accidental
    biological threats that could cause deadly large-scale animal
    outbreaks--epizootics--or the killing off of important crops. These
    kinds of natural, deliberate and accidental biological threats could
    pose serious challenges to U.S. national security.
        The global and United States experience with Ebola in West Africa
    in 2014-2015, and then again in DRC in this last year, has given us a
    snapshot of what major epidemics can do. Ebola in West Africa sickened
    more than 28,000 and killed more than 11,000. Countries from around the
    region and different parts of the world stopped allowing travel to
    affected countries. National economies were badly damaged, and doctors
    and nurses were killed in high numbers. People lost confidence in
    government and police forces were used to create quarantines, which did
    not work. The epidemic there was only brought under control after
    enormous international collaboration with governments in the region and
    many billions of dollars spent.
        In the U.S., we saw that only a few returning people with Ebola
    caused extraordinary public anxiety. Only a few cases generated intense
    national concern, leading to major response efforts by the
    Administration, as well as the attention of Congress and multiple
    governors and state governments. While this Ebola experience in the
    U.S. did not in and of itself pose national security consequences, it
    is easy to extrapolate the enormous security and economic impact if
    there were hundreds or thousands of cases of Ebola in the U.S. started
    via deliberate attack. Or, imagine if the disease at hand were easy to
    spread from person to person in the U.S. (Ebola does not spready
    easily). There could be pressure to close borders, the potential for
    hospitals to collapse under pressure, scarcity of medicines or
    ventilators, impact on troop deployments, concern about safety of U.S.
    personal overseas and much more.
        We are now a year into an Ebola outbreak in DRC where approximately
    2,000 people have been killed so far. No cases of Ebola have come to
    the U.S. in this outbreak, and there are some hopeful signs that this
    DRC epidemic could be contained. But an important lesson is that
    diseases like Ebola can take hold in countries with poor public health
    infrastructure, and from these countries could have the capacity to
    spread regionally and beyond. This outbreak has teetered right on the
    edge of being out of control in this past year. If Ebola spread broadly
    outside of DRC, quite serious international security consequences would
    follow for the U.S. and its partners, affecting travel, trade and
    security, and making it hard to operate safely in important regions of
    the world.
    Drivers of the Biological Threat
        There are a number of trends that make naturally emerging epidemics
    and pandemics more likely. Many of the emerging diseases that affect
    people have jumped from animals, and people in large numbers are living
    close to animals and encroaching on previously wild ecosystems. More
    and more people live in megacities where public health and health care
    is not strong, and where disease can move quickly. Once a disease gets
    started, it can move around the world by plane in 24 hrs. The climate
    is changing--animals are moving into new places, vectors like
    mosquitoes have broader range, and pathogens will have new, more
    conducive climates to thrive. And there is growing global resistance to
    antimicrobials that we have relied upon.
        In the realm of deliberate threats, there is continued global
    dispersion of biotechnology, which is a powerful force for economic
    growth. Genome sequencing and synthesis get continually faster and
    cheaper. In 2013, there had been several thousand human genomes
    sequenced; in 2019, there are now well over 1 million. Every government
    with any life science capability can now sequence and synthesize
    whatever it would like to. Genomes can be engineered to give them new,
    potentially dangerous characteristics, transforming pathogens that are
    now benign into pathogens that have the ability to spread or the
    ability to be lethal.
        In addition to engineered pathogens themselves being a serious
    concern, a related concern is the availability of the information
    needed to make them publicly online. If potential novel pandemic
    pathogen strains are created and the process for creating them is put
    on-line, the recipes for the creation of those novel pandemic pathogens
    will be permanently retrievable by anyone with access to the web. This
    category of problem has been called ``information hazard.''
        A key problem with biosecurity against new biological threats as it
    exists now is that new threats can emerge or be developed far more
    quickly that defenses against those threats can be made. Continuing to
    push forward with the ability to rapidly make countermeasures against
    novel threats will be pivotal. Two high-profile assassinations in
    Malaysia and the United Kingdom using chemical weapons have underscored
    the importance of ensuring capability to respond to weapons and tactics
    that use unconventional weapons.
    United States preparedness and response programs
        The 2018 National Biodefense strategy is the first U.S. biodefense
    strategy that takes on natural, deliberate and accidental biological
    threats. The strategy addresses nation-state and terrorist threats, and
    both international and domestic biological threats. It also includes a
    focus on human, animal and plant biological threats in one overall
    approach. This approach to addressing the full spectrum of biological
    threats is a potential strength and a way to enumerate all priorities
    in one place. The potential downside of a strategy with his breadth is
    that it will be challenging to assess where we stand with respect to
    all priorities articulated, and to measure progress over time for
    activities that span across government. It will be important to make
    sure agencies and offices understand their responsibilities, timelines
    and budgets for addressing the priorities in the strategy.
    Valuable DOD efforts around Biosecurity
        At a high level, it is noteworthy that the U.S. National Defense
    Strategy cites biotechnology as one of the top new technologies that
    affects the U.S. national security environment. That strategy document
    also identifies defense against biological weapons as a continued
    priority, and recognizes that bioengineering is ``increasing the
    potential, variety, and ease of access to biological weapons.'' Despite
    preparedness for biological threats being a priority in that strategy,
    our own Center's analysis shows the funding for DOD biodefense programs
    has steadily been decreasing over the last 5 years. What follows are a
    few valuable DOD biosecurity related programs that are worth
    specifically calling out.
        Joint Program Executive Office Chem Bio defense program (JPEO CB)
        The mission of this program is to ``manage the nation's investments
    in chemical and biological equipment,'' including medical
    countermeasures. There is good, new potential within this program. They
    have capabilities to characterize new biological threats, and they are
    working to create capabilities to develop countermeasures for new
    threats. They work closely with the development and surge manufacturing
    company Ology, and they have established clinical trials networks
    overseas to get new medicines into the field quickly. About 90 percent
    of the time they are working on day to day research and development for
    medical countermeasures to biological threats that are already known
    (e.g. plague), but 10 percent of the effort is dedicated to creating
    and testing capabilities (i.e. working with major cell lines for the
    range of known medicines and vaccines) that would be needed to deal
    with surprises or unknowns. The JPEO-CB program is establishing a new
    way of trying to accelerate MCM development for DOD, so it is too soon
    to know whether it will succeed as planned. But the combinations of
    science, technology, clinical trials, and manufacturing seems to have
    promise and worth supporting. The budget for this program has been cut
    in half over the last 5 years, and that seems like a mistake to me. At
    a higher DOD level, JPEO is the implementer for the DOD-wide Chemical
    and Biological Defense Program (CBD) for the Assistant Secretary for
    Defense NCB. The presidential budget for the CBD program in fiscal year
    2020 was $300 million for biodefense-related programs, while the budget
    for this program in fiscal year 2014 was almost twice that at $560
    million. We haven't reduced the number of biological threats facing the
    force (or the country) since that time. So it is illogical that the
    program has been cut nearly in half.
        DARPA Biological Technologies Office (BTO)
        The mission of BTO is to ``foster, demonstrate, and transition
    breakthrough fundamental research, discoveries, and applications that
    integrate biology, engineering, computer science, mathematics, and the
    physical sciences.'' BTO has about 10 programs with talented program
    managers from a range of scientific disciplines. They run programs on
    in issues including: engineering to develop new functional systems and
    products; developing new platform technologies for miniaturizing
    biological samples; creating systems that help support operations in
    extreme environments; protecting against emerging threats to food,
    water and agriculture; and, developing new systems to prevent and
    respond to infectious diseases. They are seeking big disruptive
    changes. For example, I have been particularly impressed with the
    Living Foundries program which ``aims to enable . . . on-demand
    production of molecules by programming the fundamental metabolic
    processes of biological systems to generate a vast number of complex
    molecules that are not otherwise accessible.'' This program's success
    has led to the DOD intention to establish a new Manufacturing
    Innovation Institute dedicated to Synthetic Biology which, while not
    associated with U.S. Biodefense, will seek to use synthetic biology to
    manufacture new products more cleanly, more sustainably and/or cheaply
    that current industrial processes. Equally impressive is the Safe Genes
    program which works to prevent ``accidental or intentional misuse of
    genome editing technologies'' by building in intrinsic biosafety
    systems within the science itself. I think the approach to biosafety in
    this program should really be a model for other BTO work and for USG
    funded work around bioengineering of pathogens. BTO overall has an
    approach to life sciences research and development that is unique in
    the government and really should be supported. The proposed 2020
    Administration BTO budget for this was \1/3\rd of its budget from the
    year before and that kind of cut would be a mistake.
        Biological Threat Reduction Program (BTRP) of the Cooperative
            Threat Reduction Program (CTR) in the Defense Threat Reduction
            Agency (DTRA)
        The mission of BTRP is ``enhance disease detection, diagnosis,
    surveillance, and reporting capabilities; develop human resource
    expertise in public and animal health; promote safe and secure
    laboratory working environments; and consolidate pathogens of security
    concern into a minimal number of safe and secure facilities in a
    sustainable manner.'' (cf program website) For example, they have
    helped to build labs in Uganda and in Liberia where early warning on
    disease outbreaks can help mobilize response more quickly. Their labs
    have helped in the Ebola response in the West Africa Ebola response.
    They provide biosafety and biosecurity programs around the world,
    including recently in North Africa where there is concern about violent
    extremist organizations. Through efforts of the BTRP program, national
    experts from Algeria, Egypt, Libya and Tunisia were trained and
    returned home better skilled to teach biosafety and biosecurity around
    their countries. They are doing this work in 29 countries and have
    developed strong working partnerships in these places.
        strategic recommendations with relevance to dod and broader usg
    Support key USG programs to accelerate MCM development process
        In addition to the DOD programs aimed at R&D for MCM development,
    there are key MCM related efforts at NIH, BARDA, FDA and CDC. For
    example, BARDA has developed 52 licensed products for biodefense, runs
    the Bioshield program for MCM procurement, and has a large pandemic flu
    effort. But it has not been funded to develop a strong program on new
    vaccines for Emerging Infectious Diseases and unknown novel threats.
    BARDA has done advanced development work on Ebola and Zika in crises,
    but then when the crisis passes it does not have the funding to create
    a full-scale organization dedicated to rapidly creating MCMs for novel
    biological threats that could emerge from nature or deliberate weapons
    use. I think these efforts to build capabilities for EIDs and unknown
    threats (in addition to the JPEO CB efforts around development and
    manufacturing) should be strongly supported with new funding.
        A recent bio-exercise our Center held, Clade X, shed light on how
    crucial medical countermeasures would be in the event of a severe
    pandemic, and how current timelines for production are too slow to be
    meaningful. Clade X also showed how biological crises could affect
    national decision making around travel and trade, the use of medical
    and scientific assets overseas in a crisis, troop deployments, civil
    liberties around quarantine, and the national allocation of scarce
    supplies of vaccine.
        Given how crucial the availability of MCMs will be to any
    biological crisis in the future, we need to keep pushing these programs
    and technologies forward, trying different models, different
    technologies, and explore new arrangements with industry. There should
    be substantial investment into platform technologies and broad-spectrum
    antivirals. There should be a major program in the USG (BARDA and DOD)
    focused on developing MCMs for unknown or novel threats. It's also
    critical for the USG to work more effectively with the biopharma
    industry to make products we will need in a crisis. The USG cannot make
    products effectively without industry, but it has been a sometimes
    fickle partner that encourages industry to do substantial amounts of
    work but then has sometimes dropped the ball quickly when a crisis
    starts to resolve.
    Approach risk assessment strategically and safely
        The process of risk assessment involves understanding science,
    intelligence, vulnerability. It also needs to incorporate the
    possibility of surprise, and the chance that the USG may receive no
    intelligence or scientific warning regarding new biological threats.
    DHS used to have a biological threat assessment process that was one
    practical tool for trying to understand the range of biological threats
    facing the nation. DHS stopped preparing its biological threat
    assessment in the last couple years for unclear reasons, and now there
    is no overall USG risk assessment process for biological threats. A
    process should be re-established for prioritizing biological risks in
    the USG.
        Biological risk assessment in the years since 9/11 has been focused
    predominantly on terrorism risks. Inclusion of bioterrorism has its
    logic given that biological expertise is widely distributed in the
    world, and small groups of talented people could do great damage with
    biology if they had training, time and resources. However, there has
    been insufficient attention in risk assessment efforts concerning
    threats posed by other countries. State actor programs should be
    specifically included in bio risk assessment. The USG bio risk
    assessment in the past also did not take into account the potential for
    omnicidal terrorist groups, movements or cults that have apocalyptic,
    population reduction, or other catastrophic goals. That should change
    now.
        While establishing a rigorous bio risk assessment is valuable and
    necessary, it is very important that it does not prompt the creation or
    lab or field testing of novel pathogen strains with epidemic or
    pandemic potential. Neither the USG nor other governments should be
    creating highly dangerous new strains of epidemic pathogens for the
    purpose of demonstrating that such strains could be created by our
    adversaries. Not only could such strains inadvertently escape a
    laboratory, they could also be deliberately removed from a lab and used
    to do great harm. Science now has the potential to create strains of
    pathogens that could self-propagate in society beyond our ability to
    respond to them and initiate new epidemics. The USG should not support
    work in this realm unless there is an extraordinary justification, with
    very high benefits that would warrant the risks and which could be
    achieved in no other way.
    Risk assessment should include a focus on the possibility of
            catastrophic biological risks
        The USG risk assessment process for biological threats should
    include within its scope the possibility of global catastrophic
    biological risks. These would be events, whether naturally emerging or
    reemerging, deliberately created and released, or laboratory engineered
    and escape, that could lead to sudden, extraordinary, widespread
    disaster beyond the capability of national and international
    governments and the private sector to control. If unchecked, these
    kinds of events could lead to not only loss of life but also sustained
    damage to the USG, other governments, economies, societal stability, or
    global security. Examples of this kind of event could include smallpox
    for many parts of the world (though less so for the U.S. that now has
    vaccine); a novel highly transmissible H5N1 bird flu that could infect
    humans with its current case fatality rate of 50 percent; and
    bioengineered viruses that threaten either the food supply broadly, or
    that target specific populations. Even if USG decision makers deem the
    probability of these threats taking place to be low, the consequences
    of them should they occur are enormous enough to warrant specific
    attention from USG policy and programs, including the above mentioned
    programs for rapidly responding to unknown threats with MCM
    development, scale up and surge manufacturing.
    Support the BWC and ways to increase international assurance
        National security decision makers in the USG--the NSC DOD, DOS,
    Congress, etc.--should strongly support bio non-proliferation efforts,
    particularly those related to the strengthening of the Biological
    Weapons Convention (BWC). The BWC has established a very important norm
    in the world against the development and use of biological weapons.
    While various public assessments have concluded that some countries
    secretly pursue biological weapons, no country openly admits to
    creating or developing biological weapons. Because there is a strong
    taboo against them, there is no open biological arms race. The USG
    should continue to do what it can to bolster that deeply valuable norm,
    and to build mechanisms between countries that can offer assurance that
    countries are not pursuing biological weapons programs.
    Strengthen US Agricultural biodefense
        In recent years, I have been very happy to see an increase in
    attention by USDA to Agricultural biological threats, whether they come
    from natural or deliberate cause. There are many important elements of
    U.S. Agrodefense including the coming opening of NBAF for research, and
    the intramural research that ARS and extramural work that NIFA support
    on these issues. The USDA has a number of surveillance systems in
    place, and it has a laboratory network for diagnosing animal diseases
    and plant diseases. There is a National Veterinary Stockpile for
    countermeasures to serious animal diseases. There are USDA offices in
    every county in the country. And USDA was a key partner in the
    development of the National Biodefense Strategy.
        Despite many positive elements of Ag defense and recent positive
    trends, there are things that need to be strengthened. There should be
    some kind of overall risk assessment process for Agricultural
    biological threats, or at least one by class of animal and plant. The
    Agricultural Research and Development Authority (AGARDA) was authorized
    in 2018 for up to $50M but is not yet funded. Plant surveillance for
    the most serious diseases is weak compared to livestock animal
    surveillance efforts. Wildlife surveillance for emergence of new
    diseases, too, should be strengthened. The Veterinary Stockpile budget
    is small about 100 times smaller than the human SNS. And overall the
    budget for USDA programs on Ag defense is not enough for the programs
    that are needed.
    Recognize the role of the private sector in preparing for, responding
            to biological threats
        The country relies on the private sector to make the vaccines,
    medicines, diagnostics and medical equipment etc that we need to
    respond. It is less well recognized that the private sector will also
    be responsible for making travel and trade systems continue to function
    in a pandemic. The private sector will need to keep supply chains open,
    run communication channels for the public and carry out many other
    critical functions. Together with the Bill and Melinda Gates foundation
    and the World Economic Forum, our Center ran an international pandemic
    exercise in NY last month called EVENT 201. This exercise showed how
    dependent national governments and international organizations would be
    on many domains of the private sector in a pandemic crisis. We would
    need systems to keep planes flying and ships moving despite infectious
    disease risks. International partnerships with the private sector would
    be needed to make decisions about distribution and allocation of
    vaccines--if they are made in country X, will other countries in the
    world be able to access them? Should there be central stockpiles at the
    World Health Organization for new pandemic diseases? And the private
    sector will be central to financial response in a pandemic--not just
    funding for the direct public health and medical response to a
    pandemic, but how to keep finance systems functioning, make sure there
    are not banks or companies too big to fail in ways that could start to
    unravel international finance systems.
    Promote and Ensure the U.S. Bioeconomy
        An important part of the U.S. economy is built on biotechnology,
    including in the realms of new medicine and vaccine development, food
    production, energy, and industrial processes. The success of the U.S.
    Bioeconomy is important to national security. Other governments have
    recognized the tremendous potential value of the bioeconomy and are
    making investments in U.S. companies, and the U.S. needs to have a
    strategy to grow and retain its biotech industries and workforce. The
    U.S. Government should move toward contracting mechanisms that
    recognize many of the in-kind benefits of biotechnology. Fuels,
    specialty chemicals, and other products made using biological processes
    may be expensive in comparison to products made through more
    traditional approaches, but the higher cost does not include the
    potential benefits of biologically processed products, including
    sustainability, reduced logistics costs if the biologically produced
    products can be produced closer to where they are needed, opportunities
    to alleviate supply chain constraints or avoid disruptions, and
    avoidance of environmental contamination and damage.
        The USG should also identify ways to recruit and retain talent
    needed to run innovative biotechnology R&D programs. It should initiate
    the tracking of data around the biotech workforce and company formation
    as these data compared to other countries. Data on the U.S. brain drain
    in science and technology is available from the academic perspective
    through the National Science Foundation, but there is limited data from
    the industry perspective. The USG should consider strategic use of non-
    dilutive capital, matched by VC investments, to help drive the creation
    of key biotech companies that would be important to the U.S.
    bioeconomy. If the U.S. Government were more explicit about what kinds
    of biotechnology-derived products it may need, the biotechnology
    industry could be more valuable to the government. There are direct
    applications of synthetic biology beyond medical countermeasures that
    offer value to the U.S. economy and defense. Products such as
    biologically made concrete, cloth, caffeine production, food, and rare
    earth mining are just a few biotechnologies that may be valuable to the
    government or to defense. In addition, there are medical benefits,
    including regenerative manufacturing of organs or human tissue, that
    may benefit injured warfighters.
    Conclusion
        In summary, there are a range of natural, deliberate and accidental
    high consequence biological threats facing the country. The Dept of
    Defense has responsibilities, programs, science and assets that are
    critical in efforts to prevent, detect and respond to those biological
    threats. The DOD's efforts are part of a larger USG national biodefense
    strategy and set of programs that are key to preparing the country for
    major biological events. It is critical that DOD continue to invest in
    and prepare for biological threats, particularly for high consequence,
    even catastrophic biological events, that could have national security
    implications, either through direct serious health and life risks to
    troops, challenges to deployments, interruptions to logistics, illness
    in family members, major damage to the economy, or other major shocks
    and disruptions to the country.

        Senator Ernst. Thank you, Dr. Inglesby.
        Dr. Gerberding, please.

     STATEMENT OF DR. JULIE L. GERBERDING, CO-CHAIR, COMMISSION ON
     STRENGTHENING AMERICA'S HEALTH SECURITY, CENTER FOR STRATEGIC
                       AND INTERNATIONAL STUDIES

        Dr. Gerberding. Good afternoon and thank you. Chairwoman
    Ernst, Ranking Member Peters, and all of the staff of the
    subcommittee, thank you for paying attention to this really
    important national issue.
        I am pleased to discuss with the subcommittee the
    recommendations of a report from the Center for Strategic and
    International Studies Commission on Strengthening America's
    Health Security. The full report was released today, and it is
    entitled ``Ending the Cycle of Crisis and Complacency.''
        I co-chair this commission with former Senator Kelly
    Ayotte. Members of Congress who serve as commissioners include
    Senators Murray and Young and Representatives Bera, Brooks,
    Cole, and Eshoo. We also are served by several biosecurity
    experts from around the country, and their commission work is
    still ongoing.
        We began our work with an indisputable premise, and that is
    that biological threats, whether from natural, intentional, or
    accidental causes, are occurring more often and have the
    potential to cause unprecedented harm to Americans and to
    people around the world.
        The world we live in now is amazingly insecure, violent,
    and disordered, and it is exactly in these circumstances that
    these biologic threats emerge and spread. All we have to do is
    look at the DRC [Democratic Republic of the Congo] situation
    with Ebola to understand the complexity and the opportunity for
    emergence.
        Not only is our disordered world more conducive to the
    emergence of biothreats, but we are also, of course,
    increasingly connected and interdependent. Globalization,
    international trade and travel all mean that an outbreak in one
    part of the world can very quickly be a threat to us here in
    the United States. In other words, a threat anywhere is a
    threat everywhere.
        In that context, health security threats truly are national
    security threats, and that brings them right into the domain of
    the subcommittee.
        Unfortunately, despite the fact that policymakers know to
    invest in threats when they emerge, all too often the
    recognition occurs only after a health crisis strikes. I
    certainly experienced exactly that in my government tenure with
    the anthrax, SARS, West Nile, avian influenza outbreaks. My
    successors at CDC [Centers for Disease Control and Prevention]
    have experienced the same thing with an influenza pandemic,
    MERS, Ebola, Zika, and so forth.
        When biothreats are recognized, policymakers do allocate
    emergency resources, but critical time, sometimes weeks to
    months, passes before these resources are available, and in
    that time, lives are lost.
        Once the crisis fades and public attention subsides,
    urgency morphs into complacency, investments dry up, attentions
    shift, and a false sense of security takes hold.
        The commission asserts that the U.S. Government has to end
    this cycle of crisis and then complacency. We need to replace
    it with a doctrine that can guarantee continuous prevention,
    protection, and resilience.
        In that spirit, we commend the release of the National
    Biodefense Strategy last fall and the Global Health Security
    Strategy this year. These do provide a solid foundation, but we
    need action.
        What the commission has presented in its report today is an
    agenda for specific actions that the Congress might undertake
    to try and strengthen our ability to be prepared and respond to
    health security threats.
        I do not have time to go into all of these. They are
    outlined in the summary report. But we do have a couple that we
    wanted to highlight because we think they would be especially
    germane to the subcommittee.
        First and foremost, we think it is important that we
    clarify what leadership at the National Security Council is
    accountable for the overall government engagement in health
    security threats. Right now, it is unclear who would be in
    charge. Strong, coherent leadership at the National Security
    Council is essential to guaranteeing effective oversight long
    before crises emerge.
        We also recommend actions to augment the important role
    that the Department of Defense plays in health security. One
    important area is DTRA [Defense Threat Reduction Agency], and
    we believe that DTRA should have extended authority to operate
    in all continents where health security threats exist.
        Furthermore, the support for the military's infectious
    disease research laboratories should be strengthened. During my
    tenure, I had the opportunity I think to visit all of the Navy
    and Army laboratories around the world, and I saw firsthand how
    critical they were in the front line of influenza preparedness,
    but also the broad investment in developing and researching
    other infections diseases that are not necessarily studied by
    other agencies or for which countermeasures would not be
    developed at all. I think these laboratories are a national
    treasure, a critical front line of our global surveillance and
    response, and we must continue to support them.
        The last point I would like to comment on is the importance
    of our ability to rapidly respond to emerging threats and
    mitigate harm to affected people. The contingency fund levels
    for CDC and USAID [United States Agency for International
    Development] should be increased and sustained. In addition, we
    should establish a U.S. global health crisis response corps,
    which is based on existing CDC and USAID capabilities, but to
    have this team with the trained and exercised ability to
    deployed and work with local partners in health crisis
    settings, even when those settings are insecure.
        In summary, the commission urges Congress to invest in
    biothreat reduction as the national security imperative. We
    believe the long-term costs of strategic protection and
    prevention are but a tiny fraction of the astronomic costs of
    episodic and too often chaotic responses to emerging crises.
    These smart investments would draw support from all.
        Thank you for the opportunity to testify. It is really my
    hope that we can end this cycle of crisis and complacency, and
    I request that the CSIS report on Ending the Cycle of Crisis
    and Complacency be submitted for the record. Thank you.
        Senator Ernst. Without objection.
        [The CSIS report on Ending the Cycle of Crisis and
    Complacency can be found in Appendix A.]
        [The prepared statement of Dr. Gerberding follows:]

                 Prepared Statement by Dr. Julie L. Gerberding
        Chairwoman Ernst, Ranking Member Peters, and other distinguished
    Members of the Subcommittee--I am truly grateful for the opportunity to
    appear before you today. The topic of biological threats to U.S.
    national security remains vitally important and is deserving of far
    greater consideration. Thank you for your leadership in this critical
    area.
        The timing of today's hearing is especially propitious, since it
    falls on the very day that we are releasing the full report of the
    Center for Strategic International Studies (CSIS) Commission on
    Strengthening America's Health Security, entitled Ending the Cycle of
    Crisis and Complacency.
        I co-chair that Commission with former Senator Kelly Ayotte. CSIS
    launched the Commission in April 2017. It includes among its very
    active members Senators Patty Murray (D-WA) and Todd Young (R-IN),
    Representatives Ami Bera (D-CA), Susan Brooks (R-IN), Tom Cole (R-OK),
    and Anna Eshoo (D-CA), along with 12 other diverse leaders, including
    from the security world General Carter Ham, Admiral Jonathan Greenert,
    Christine Wormuth, and Rebecca Hersman.
        We will make available the full Commission report for the
    Subcommittee.
        Given the Subcommittee's agenda, please allow me to lay out
    succinctly the central premises that guide our work, along with a
    summation of the Commission's recommendations. My hope is that we can
    identify today several points of common purpose in the Commission's
    work and the Subcommittee's priorities.
        We began the Commission's work with a simple, powerful proposition:
    health security is national security, in a world that is increasingly
    dangerous and interdependent.
        Biological threats--outbreaks from natural, intentional and
    accidental causes--are occurring with ever higher velocity, rapidity
    and costs. \1\ At the same time, the world is increasingly insecure,
    violent and disordered, and it is exactly in danger zones where an
    increasing number of biological outbreaks occur. \2\
    ---------------------------------------------------------------------------
        \1\ Katherine F. Smith et al., ``Global rise in human infectious
    disease outbreaks,'' Journal of the Royal Society Interface 11
    (December 2014), https://royalsocietypublishing.org/doi/full/10.1098/
    rsif.2014.0950.
        \2\ Rebecca K. C. Hersman, Meeting Security Challenges in a
    Disordered World (Washington, DC: CSIS, May 2017), https://csis-
    prod.s3.amazonaws.com/s3fs-public/publication/170522
    _Hersman_MeetingSecurityChallenges_Web.pdf?UKD0LRcihyrV02wgy9AQIQHGzhMId
    Acb.
    ---------------------------------------------------------------------------
        We need to adjust our thinking to account for this fundamental new
    reality. We need new approaches to operate effectively, on-the-ground,
    in difficult, insecure places.
        Increasing levels of disorder and conflict around the world are
    resulting in the costly destruction of public health and clinical
    infrastructure. Population growth, urbanization, and the mass movement
    of populations are forcing more people into overcrowded and unsanitary
    living conditions, creating ideal conditions for the emergence and
    spread of infectious diseases. Globalization and the rise of
    international trade and travel mean that an outbreak in a disordered
    setting with a weak health system can quickly become a pandemic,
    threatening the United States and the rest of the world. Policymakers
    increasingly appreciate these threats can undermine the social,
    economic, and political security of nations.
        The Commission also arrived at a stark, companion conclusion: U.S.
    health security policy is caught in a cycle of crisis and complacency,
    which leaves Americans very vulnerable.
        When health crises strike--measles, MERS, Zika, dengue, Ebola,
    pandemic flu--the American people grow alarmed and U.S. policymakers
    spring into action, rushing to allocate resources in response. Yet all
    too often, when the crisis fades and public attention subsides, urgency
    morphs into complacency. Investments dry up, attention shifts, and a
    false sense of security takes hold.
        That realization led us to our macro-conclusion: first and
    foremost, the U.S. Government needs to break the cycle of crisis and
    complacency and replace it with a doctrine that can guarantee
    continuous prevention, protection, and resilience.
        We are convinced that we can break this cycle. Health security and
    biodefense are areas that historically enjoy strong bipartisan support
    in Congress, healthy and fruitful cooperation between Congress and the
    Administration, and strong, promising public-private partnerships.
        Health security, luckily, is an oasis of sorts. In an era of acute
    political polarization, it is a policy zone where, across the political
    divide, we recognize our shared interests and can have informed
    discussions to chart a common path forward. We recognize that health
    security challenges are innately complex, and require all of us working
    together, across jurisdictions, agencies, and sectors, to create a much
    better line of defense. We should celebrate this good fortune and take
    full advantage of it.
        The Commission also believes that the economic case to invest early
    in preparedness and biodefense is crystal clear--and powerful. There is
    much accumulated evidence from recent outbreaks proving the
    affordability of investing in preparedness, and the huge costs of not
    investing. The United States faces a choice: it must either pay now and
    gain protection and security, or wait for the next crisis and pay a
    much greater price in human and economic costs.
        The long-term costs of strategic protection and prevention programs
    are but a tiny fraction of the astronomic costs of responding to
    sudden, emergent crises. The 2014-2016 West Africa Ebola outbreak is
    illustrative. Beyond the devastating loss of human lives, the outbreak
    had enormous social and economic costs, with global repercussions. The
    U.S. Government spent nearly $2.4 billion in emergency funding to
    support the international Ebola response. \3\ The outbreak ultimately
    cost the global economy more than $53 billion, an average of more than
    $1.8 million per Ebola case. \4\ The cost of basic preparedness in low
    income countries is roughly $1 per person per year. \5\
    ---------------------------------------------------------------------------
        \3\ ``West Africa--Ebola Outbreak, Fact Sheet #6, FY 2016,'' USAID,
    January 21, 2016, https://www.usaid.gov/sites/default/files/documents/
    1866/west _africa _fs07 _01-21-2016.pdf.
        \4\ Caroline Huber, Lyn Finelli, and Warren Stevens, ``The Economic
    and Social Burden of the 2014 Ebola Outbreak in West Africa,'' The
    Journal of Infectious Diseases 218, suppl. no. 5 (December 15, 2018):
    S698-S704, https://doi.org/10.1093/infdis/jiy213.
        \5\ The International Working Group on Financing Preparedness (IWG)
    estimates $0.50-$1 per person per year would be needed, although there
    is variation in cost estimates by country. The range of $0.50-$1.50
    captures most reasonable estimates. See: International Working Group on
    Financing Preparedness, From Panic and Neglect to Investing in Health
    Security.
    ---------------------------------------------------------------------------
        The Commission commends the recent advances in U.S. health security
    and biodefense policy, including the release of the National Biodefense
    Strategy last fall and the Global Health Security Strategy this year.
    \6\\7\ These are positive steps forward, which we should build upon.
    ---------------------------------------------------------------------------
        \6\ White House, National Biodefense Strategy (Washington, DC:
    September 2018), https://www.whitehouse.gov/wp-content/uploads/2018/09/
    National-Biodefense-Strategy.pdf.
        \7\ White House, United States Government Global Health Security
    Strategy (Washington, DC: 2019), https://www.whitehouse.gov/wp-content/
    uploads/2019/05/GHSS.pdf.
    ---------------------------------------------------------------------------
        What is urgently needed, in our opinion, is concrete, concerted
    action by Congress and the Administration.
        The CSIS Commission on Strengthening America's Health Security
    advocates for a package of strategic, affordable actions to advance
    U.S. health security. In combination, these actions constitute a
    doctrine that can guarantee continuous prevention, protection, and
    resilience.
        First and foremost, we recommend that health security leadership at
    the White House National Security Council (NSC) be restored.
        Today, it remains unclear who would be in charge at the White House
    in the event of a grave pandemic or cross-border biological crisis,
    whether natural, accidental, or deliberate. The lack of clarity is
    dangerous and should be rectified. Furthermore, strong, coherent
    leadership at the NSC is essential to guarantee effective oversight of
    global health security and biodefense policy and spending. With that
    leadership in place, it becomes possible to achieve higher efficiencies
    in the use of scarce resources, overcome fragmentation and redundancy
    of programs, and ensure greater rigor and accountability.
        We advocate for the right mix of quality investments of resources.
        We need to invest directly and consistently over the next decade in
    the capacities of low-income countries. Such a long-term, predictable
    approach is essential, if basic preparedness is to be created.
        The best approach to protect the American people is to stop
    outbreaks at the source. The Global Health Security Agenda, or GHSA,
    established in 2014, is designed to do just that. \8\ GHSA has a proven
    track record in building health systems and health security
    preparedness in low- and middle-income countries, financed through a $1
    billion Ebola emergency supplemental funding. \9\ We should sustain
    that record of success, not disrupt or curtail it.
    ---------------------------------------------------------------------------
        \8\ The GHSA is coordinated by a multilateral steering group
    comprised of 10 countries, including the United States, and is advised
    by several international organizations including the WHO, Food and
    Agriculture Organization (FAO), the World Organization for Animal
    Health (OIE), the World Bank, and Interpol. See: ``Membership,'' Global
    Health Security Agenda, updated March 26, 2019, https://
    www.ghsagenda.org/members.
        \9\ ``Implementing the Global Health Security Agenda: 2017 Progress
    and Impact from U.S. Investment,'' GHSA, February 2018, https://
    www.ghsagenda.org/docs/default-source/default-document-library/global-
    health-security-agenda-2017-progress-and-impact-from-u-s-
    investments.pdf ?sfvrsn=4.
    ---------------------------------------------------------------------------
        The DOD contributes to this and other U.S. health security efforts
    through a number of programs that are aimed at countering biological
    threats from all sources. \10\ The DOD operates a worldwide public
    health, infectious disease research, and disease surveillance network
    to protect U.S. and allied forces against infectious diseases and other
    biological hazards. Critical programs include the DOD Defense Threat
    Reduction Agency's (DTRA) Cooperative Threat Reduction (CTR) Biological
    Threat Reduction Program (BTRP) and the DOD Global Emerging Infections
    Surveillance and Response (GEIS) Program. \11\ \12\ These programs
    benefit both the military and the general public. They should be
    protected and strengthened.
    ---------------------------------------------------------------------------
        \10\ For more detail on how the DOD supports U.S. global health
    security efforts, refer to Thomas R. Cullison and J. Stephen Morrison,
    United States Department of Defense Role in Health Security
    (Washington, DC: CSIS, June 27, 2019), https://healthsecurity.csis.org/
    articles/the-u-s-department-of-defense-s-role-in-health-security-
    current-capabilities-and-recommendations-for-the-future/.
        \11\ ``Cooperative Biological Engagement Program,'' Defense Threat
    Reduction Agency, http://www.dtra.mil/Missions/Partnering/CTR-
    Biological-Threat-Reduction/.
        \12\ See James B. Peake et al., The Defense Department's Enduring
    Contributions to Global Health _The Future of the U.S. Army and Navy
    Overseas Medical Research Laboratories (Washington, DC: CSIS, 2011),
    https://www.csis.org/analysis/defense-department's-enduring-
    contributions-global-health.
    ---------------------------------------------------------------------------
        Specifically, we recommend that the U.S. Government expand DTRA's
    geographic authorities to operate in all continents where health
    security threats exist, including South America. Furthermore, support
    for military overseas infectious research laboratories should be
    sustained. DOD biological research and development programs often focus
    on diseases not studied in other venues and result in medical
    countermeasures that would otherwise be delayed or not developed at
    all.
        We need to exercise multilateral leadership to persuade partner
    countries to invest more of their own resources in preparedness.
        The financing gap in preparedness is, arguably, the most glaring
    problem we face in global health security. In the poorest and most
    fragile countries, where many needs are pressing and resources are
    constrained, leaders often face difficult trade-offs between investing
    in preparedness versus more tangible efforts like building roads or
    schools. Congress should press
        for U.S. leadership to launch a five-year challenge initiative at
    the World Bank that would incentivize long-term investment by fragile
    and conflict-affected countries in their own basic health security
    capacities. The United States would, under this plan, shoulder 20
    percent of the donor costs over the five-year period, using its
    influence to leverage other donors to cover the remaining 80 percent.
    The goal is that low-income countries eventually assume higher and
    higher responsibility for their preparedness. Such ownership is the
    only sustainable solution to the finance gap.
        We need far better confidence that we can access adequate, quick-
    disbursing resources when a health or biosecurity crisis strikes.
        We simply cannot afford costly delays while scrambling to assemble
    resources. During moments of crisis, swift and early action is most
    essential. The Commission recommends that Congress increase contingency
    funding levels for the CDC and USAID, and that the U.S. Government make
    annual contributions to the WHO's Contingency Fund for Emergencies.
        The Commission argues that we need to launch initiatives that will
    allow us to operate far more effectively in insecure settings.
        The disordered world spans chronic and emerging conflicts,
    humanitarian crises, fragile states, and mal-governed and stateless
    spaces. The world is becoming more dangerous and insecure, and it is
    those very places where dangerous outbreaks are often occurring:
    witnessing what is unfolding in the Democratic Republic of the Congo,
    Syria, Yemen, Afghanistan, Pakistan, and Venezuela.
        In the meantime, however, access by U.S. civilian outbreak response
    experts into these insecure settings has become highly problematic.
    Across several cases, we see seasoned U.S. experts--the ``cerebral
    cortex'' to lead the international response--confined to the sidelines.
        The Commission advocates for the establishment of a U.S. Global
    Health Crises Response Corps, which will build upon and integrate
    existing CDC and USAID capabilities, to work with local partners to
    respond early to outbreaks and biosecurity incidents in disordered and
    insecure settings. This is a civilian capacity, which would have a DOD
    advisor. It would receive specialized training and exercises in
    building teams and would be provided with special support in terms of
    communications, intelligence, entry and exit protocols, and language
    and local mediation skills. It would also be equipped to strengthen
    local capacities to deliver services.
        The Commission also advocates that the U.S. Government strengthen
    and adapt programs and capacities to deliver health services in fragile
    settings that meet the special needs of acutely vulnerable populations,
    especially women and children. This means ensuring the continuity of
    immunization programs, the protection against and response to, gender-
    based violence (GBV), and strengthening the delivery of maternal and
    reproductive health and family planning assistance. \13\
    ---------------------------------------------------------------------------
        \13\ Fleischman, Janet, How Can We Better Reach Women and Girls in
    Crises? (Washington, DC: CSIS, October 2019) https://
    healthsecurity.csis.org/articles/how-can-we-better-reach-women-and-
    girls-in-crises/.
    ---------------------------------------------------------------------------
        The last area of priority concern to the Commission is the
    revolution underway in the life sciences, driven by technological
    transformations that pose both opportunities and risks.
        There is a race underway to develop new vaccines, therapeutics, and
    diagnostics in light of the mounting risks of emerging infectious
    diseases and growing resistance. It is essential to plan strategically,
    with strong private-sector partners, to support targeted investments
    that will accelerate the development of new technologies for epidemic
    preparedness and response. We argue that the U.S. Government should
    directly invest in the Coalition for Epidemic Preparedness Innovations,
    or CEPI, an international alliance that finances and coordinates the
    development of new vaccines to prevent and contain epidemics. The U.S.
    Government should also redouble its efforts to develop a universal flu
    vaccine and new antibiotics.
        We are also facing an unforeseen communications crisis in public
    health, fueled in part by the rapid spread of misinformation and
    disinformation online through weaponized social media. When
    misinformation crowds out facts, confidence in public health and
    medicine can erode precipitously, causing outbreaks of preventable
    diseases such as measles and polio. Congress should press for the U.S.
    Government to expand its efforts to better understand and address this
    complex phenomenon, effectively communicate accurate science to the
    American people, restore trust and confidence, and reclaim social media
    as a force for good in public and global health.
        Again, thank you for the opportunity to address you today, and I
    look forward to hearing your perspective. It is my sincere hope that we
    can work closely together to advance the U.S. health security agenda.

        Senator Ernst. Dr. O'Toole, thank you.

     STATEMENT OF DR. TARA J. O'TOOLE, SENIOR FELLOW AND EXECUTIVE
                        VICE PRESIDENT, IN-Q-TEL

        Dr. O'Toole. Thank you, Madam Chairman, ranking member, for
    the invitation to talk about this very important and----
        Senator Ernst. Do you have your mic on?
        Dr. O'Toole. Thank you for having me here today and for
    holding this hearing on this very important, complex, and I
    think relatively neglected topic.
        As my two eminent colleagues have described, these
    biothreats are various, and all of them are quite terrifying.
    But I would like to suggest a hierarchy of biothreats that is a
    little different.
        First of all, we do live in an age of epidemics, and this
    is not going to change. It is a consequence of trade and travel
    patterns and the rise of urbanization in situations where
    people live in conditions of poor sanitation, nutrition, et
    cetera.
        Secondly, we have the deliberate bio-attack threats.
    Bioweapons have been with us a long time, but because of the
    revolution in biology that is going on, we have the capacity to
    make new, more powerful bioweapons that could evade all of our
    capacity to diagnose them and to treat them. It is very
    unlikely, given the difficulty of gathering intel on these
    programs, that we will have advance tactical knowledge of what
    weapon we might be facing or even where it might come from
    because I think, as the ranking member said, more and more
    people are going to have access to this technology as it
    becomes a foundational technology of the 21st Century economy.
        The third threat and in my mind in some ways worse than the
    first two is that we will fail to win the economic competition
    for the biorevolution. There is no question that we are in a
    geopolitical competition to wield these new technologies which
    I believe are going to undergird much of the 21st Century
    economy. I want to spend most of my time talking about that.
        We are in the situation today with regard to bioweapons and
    the threat of bioterror because of the advances that have been
    made in the life sciences in the past 40 years and the
    convergence of those advances in biology and biotechnology with
    digitalization.
        What we now understand is that biology is programmable.
    Life runs on code. It is not 1's and 0's. It is nucleic acids
    that make up the code, but we are beginning--we are past
    beginning--we are now able to read, write, and edit that code.
    Our ability to do so is improving exponentially, faster than
    Moore's Law.
        This is going to be phenomenally beneficial. It is going to
    impact multiple different industries, not just biomed, not just
    agriculture. That is because one of the industries that is
    rising is that of synthetic biology. Organisms are becoming
    programmable manufacturing systems, and we are already using
    organisms to make flavors, fragrances, new fabrics, materials
    with totally previously unknown properties, et cetera. Biology
    is likely to become the fundamental manufacturing platform of
    the future.
        We in the United States are the innovation engine of this
    new technology, and it is really several families of
    technologies. But China has said repeatedly and very
    forcefully--and they are backing up their words with actions--
    that they intend to own the biorevolution. They are building
    the infrastructure, the talent pipeline, the regulatory system,
    and the financial system they need to do that. That is before
    we even talk about the secrets and the information and the
    intellectual property they are stealing from us, which is a
    small trickle of the contributions that they are building for
    their own economy.
        They have good reasons to go after the biorevolution. They
    have a huge population. They have the highest incidence of
    cancer on earth. Their population is aging. They are going to
    need to deal with challenges like Alzheimer's, just as we are,
    and they have to find an affordable way to deliver health care
    to their rising middle class.
        But I do want to note that the United States has not done a
    good job at translating biology into products. Our
    translational infrastructure for biology is mostly coming from
    small startup companies in the private sector, which is where
    In-Q-Tel does its business. Those are the innovation engines
    for biology and much else.
        We need to think about how we would build a more robust
    infrastructure particularly to manage epidemics, whether they
    are deliberate or natural. For example, we need to have the
    capacity, once an epidemic is noted, to immediately create
    diagnostics that could be used like pregnancy tests by the
    people themselves to determine who is sick and who is not. That
    would be strategically invaluable in managing the epidemic. We
    need to be able, as Dr. Inglesby suggested, to rapidly develop
    a new vaccine in response to an epidemic. We are within reach
    of technologies that can do that. We need to get much more
    ambitious as a country in how we are going to prepare for
    bioattacks and for natural epidemics. But we also need to tend
    to building infrastructure for securing and promoting the
    bioeconomy.
        Thank you.
        [The prepared statement of Dr. O'Toole follows:]

                  Prepared Statement by Tara O'Toole, MD, MPH
        Good afternoon, Chairman Ernst, Ranking Member Peters, and
    distinguished members of the Subcommittee. Thank you for the
    opportunity to appear before you today to discuss how the Department of
    Defense can help counter the potential biological threats facing
    Americans.
        I have worked as a practicing physician, but much of my career has
    been spent in academia and government. I was a program manager at the
    Congressional Office of Technology Assessment, served as Assistant
    Secretary of Energy, and founded and led the Johns Hopkins and
    University of Pittsburgh biodefense centers from 1999-2009. I served
    five years as Under Secretary of Homeland Security for Science and
    Technology, where I oversaw the National Biodefense Analysis and
    Countermeasures Center and supported the creation of a new National Bio
    and Agro-Defense Facility. In 2014, I became executive vice president
    and senior fellow at In-Q-Tel (IQT), a non-profit investor for nine
    United States national security agencies, accelerating and shaping
    commercial startup technologies to advance the national interest.
        I appreciate the opportunity to come before you today and commend
    the Subcommittee for addressing this vital and neglected aspect of
    national security. I would like to emphasize four points.

            First, rapid advances in the life sciences, biotechnology, and
            artificial intelligence, plus what we know about our
            adversaries' programs, require a fundamental shift in United
            States biodefense strategy. New and evolving technologies have
            enabled a more dangerous and dynamic biothreat landscape than
            is contemplated in current biodefense policy and programs.

        The past decades of biological science have brought us an array of
    powerful technologies such as DNA sequencing, gene editing, and
    synthetic biology. These and other advances have caused a revolution in
    our understanding of, and ability to alter, living organisms. We have
    learned that biology is essentially programmable: life runs on code.
    The knowledge and technologies needed to read, write, and edit this
    code are improving exponentially--faster than Moore's Law. In other
    words, the code of life, which consists of four different base pairs
    instead of ones and zeros, is being digitized, and this information is
    being stored in huge genomic data banks.
        These capabilities have and will continue to generate great
    benefits across a range of industries, such as new approaches to cancer
    treatment, and extremely efficient ways to produce complex chemicals
    and new materials. But these capabilities can also be exploited for
    evil purposes.
        All powerful technologies can be dual-use, and this is particularly
    true of modern biotechnologies. The same methods that enable the repair
    of genes which cause disease, allow us to genetically engineer bacteria
    to produce insulin, or alter a virus to create a vaccine, can be
    employed to create pathogens not seen in nature. Such pathogens, which
    could affect humans, animals, or plants, could be constructed to be
    particularly virulent, evade conventional diagnostic tests, or to
    resist available drugs and vaccines.
        As bioengineering methods advance, and especially as artificial
    intelligence methods are applied to DNA sequencing, synthesis, and
    editing, the deliberate creation of new pathogens will be within reach
    of many more actors. In addition, because techniques such as genomics
    and gene engineering are so useful in so many industries, and will be
    so central to the blossoming bioeconomy, more and more people around
    the world will have access to these technologies and know how to use
    them.
        The United States had a powerful, secret offensive biological
    weapons program during the Cold War, which lasted until 1969. Most
    people today, even in the military, do not understand how effective and
    advanced these programs were. The bioweapons we built then were
    intended to be strategic weapons, like nuclear weapons. The country
    tested these bioweapons in all conditions short of actual conflict and
    demonstrated them to have the large area coverage and lethality of
    nuclear weapons. And this was accomplished using 1960s technologies.
        Given the unavoidable expansion of these dual-use biotechnologies;
    the absence of any enforceable national treaties controlling bioweapons
    production and use; and the rise of competitive peer state adversaries;
    the United States must urgently consider how it will defend itself
    against what could be an existential threat to civilian populations,
    our agricultural assets, and warfighters.
        In addition to these man-made biological threats, we live in an age
    of epidemics. Naturally-occurring outbreaks of infectious disease have
    increased in frequency and impact over the past two decades. They are
    the consequence of modern trade and travel patterns, human intrusion
    into once remote ecosystems, and global urbanization with its attendant
    problems of poverty and poor sanitation. As has been seen with human
    outbreaks of SARS, MERS, Ebola, and Zika, and the ongoing epidemic of
    African Swine Fever in Asia which has resulted in the deaths of over
    300 million pigs, these outbreaks impose tragic costs in terms of
    death, suffering, economic losses, and social upheaval.

            Second, the United States should aggressively develop and apply
            new and emerging technologies to create new capabilities needed
            for a robust biodefense against natural and man-made
            biothreats. Such a strategy would have the additional benefit
            of strengthening United States competitiveness in the global
            economy.

        The 2018 National Biodefense Strategy (NBS), many years in the
    making, is a detailed and coherent declaration of the broad
    capabilities needed to prevent, detect, contain, and recover from
    naturally-occurring epidemic disease. The NBS does not, however,
    recognize the urgency or potential challenges of protecting the nation
    from deliberate and covert bioweapons attacks, which could be far more
    devastating than even the most serious natural outbreak. The NBS also
    lacks a mechanism for continuous monitoring of the capabilities
    inherent in rapidly evolving biotechnologies. Nor does the document
    assign priorities, confer authorities commensurate with stated
    responsibilities, or provide new resources. Critically, in my view, it
    lacks a viable, appropriately ambitious, strategic plan for biodefense
    technology development.
        The biothreats posed by new biotechnologies, the potential for
    large-scale outbreaks in this age of epidemics, the rise of powerful
    nation state adversaries, and the feasibility of non-state actors
    wielding bioweapons, requires that the United States immediately commit
    to significant investments in developing and deploying the technologies
    needed for biodefense.
        To start, the national security community needs to develop a more
    realistic understanding of biothreats and their underlying dynamics.
    This will require competence in genomics, proteomics, computer science,
    and artificial intelligence--skills in short supply across the
    government. Also needed is a much more ambitious, strategic approach to
    the technologies needed for biodefense--that is, for detecting,
    managing, and quenching epidemics, including epidemics caused by
    pathogens not previously seen in nature, and possibly designed by
    humans.
        Relying on traditional, slow, and costly methods of drug and
    vaccine development and hoping that what we need will be available in
    expensive (and inevitably inadequate) stockpiles of medical
    countermeasures will not suffice. What is needed is a national
    commitment to the develop technologies that, for example, would enable
    rapid design and manufacture of medical countermeasures (diagnostic
    tests, vaccines, and therapeutics) at scales and in timeframes that
    could impact management of a large, lethal, and fast-moving epidemic.
    Also needed--and in use commercially today--are technologies that
    provide situational awareness during outbreaks. This requires the
    collection, wrangling, and analysis of essential data needed to make
    informed decisions about epidemic management. Such technologies, if
    deployed, should provide a defense against both engineered bioweapons
    and newly emergent natural diseases.

            Third, Department of Defense (DOD) leadership is critical to
            United States biodefense, but talent and resources are
            currently quite limited.

        DOD has historically played a critical role in response to disease
    outbreaks overseas. The key diagnostic test, vaccine, and therapy that
    were deployed to contain the 2014 West African outbreak of Ebola virus
    would not have been available but for DOD investments in R&D. DOD's
    long experience with technological development could make significant
    contributions to protecting warfighters and civilians against natural
    and man-made biothreats. The Department is not, at present, optimally
    organized nor stocked with the sufficient trained staff to execute this
    mission.
        For several years, DOD's Defense Advanced Resarch Projects Agency
    (DARPA) has executed important projects in biotechnology, including in
    projects designed to better understand biothreats, and has recently
    expanded its Biological Technologies Office (BTO) staff and budget. The
    quality of DARPA's work is excellent, and their staff is highly expert.
    But BTO is less than 50 people. The Joint Program Executive Office for
    Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)
    also has a number of excellent people working on important aspects of
    biotechnology, focused on providing warfighters protection from CBRN
    threats. But JPEO-CBRND's mission and budget could benefit from being
    considered a higher priority within DOD.
        The Committee might consider a review of current DOD biodefense
    programs with the aims of increasing coordination, encouraging risk-
    taking, and placing an emphasis on capabilities for rapid medical
    countermeasure development, while providing sufficient resources to
    allow DOD officials to make meaningful contributions. Contract and
    budget mechanisms to effectively partner with innovative small
    companies, which populate most of the biotech landscape, will be
    essential, as will programs to recruit and retain talented scientists
    and engineers.

            Fourth, China has urgent and compelling reasons to aggressively
            pursue advancements in biomedicine and biotechnology. But
            China's geopolitical strategy to dominate the bioeconomy--and
            indeed to ``own the biorevolution''--represents as great a
            threat to United States national security as their bid to
            assert dominance in artificial intelligence, quantum computing,
            and space.

        China is planning, organizing, and financing efforts to become the
    world leader in biotechnology. The Chinese government rightly seeks
    ways to feed billions in the face of a changing climate, to bring
    medicines to a population with the world's highest cancer incidence and
    100 million diabetics, and to help its aging population stay healthy.
    Many nations share these goals, and we should find ways to cooperate to
    advance biology's humanitarian contributions.
        Yet it is also true that China sees biology as a route to expand
    its global power. China is using all the means available to an
    authoritarian state to reach its 5-year R&D plan to make the
    biotechnology sector 5% of its GDP by 2020. China is investing heavily
    in research, building new facilities, recruiting talent from abroad,
    reforming its regulations for drug approvals, establishing financial
    rules that favor Chinese companies, and linking its giant internet
    firms like Tencent and Alibaba to biotech development. Having watched
    the UK lead the industrial revolution and the United States lead the
    information revolution, China aims to capture the revolution in
    biotechnology.
        The United States should not cede this ground. The United States
    and its international partners must plan, organize, and invest to
    advance key aspects of biotechnology and then harness the vitality of
    our entrepreneurs to turn discovery into product. The first step is a
    national biotechnology strategy, one that can incorporate the vital
    contributions of the biodefense strategy but also transcend it,
    recognizing that biology will reshape world leadership as much as our
    quality of life on this planet.
                                   conclusion
        The challenge of preparing for bioattacks and epidemics, natural or
    engineered, is integrally linked to broader imperative of maintaining
    America's leadership in biotechnology. Within the national security
    community there has been much focus on artificial intelligence, which
    clearly has enormous implications for our economy and our defense
    establishment, and already shapes our shopping habits, provides big
    data analyses, and operates robots. Biology will prove equally
    transformative--Americans just do not see it yet. This is a problem
    because biotechnology is both a humanitarian and geopolitical
    necessity.
        Biotechnology will dramatically and literally reshape our lives and
    our world. It will also become a significant source of national power--
    economic, and in all likelihood military--as it creates entirely new
    possibilities, materials, and products. The question is whether our
    government can best position the United States to capitalize on this
    promise.
        Thank you.

        Senator Ernst. Thank you, Dr. O'Toole. Thank you to our
    witnesses.
        We will begin with 5-minute sessions of questioning, and I
    will go ahead and reserve my time after we get done with our
    first round here. I will go ahead and allow Ranking Member
    Peters to start with questions.
        Senator Peters. Thank you, Madam Chair.
        Actually I want to pick up on some of the comments you
    made, Dr. O'Toole. This question will be for the panel to
    expand on this.
        The United States-China Economic and Security Review
    Commission recently released its annual report to Congress, and
    in that report, the commission highlighted that following the
    2001 anthrax attacks, the United States was reliant on a single
    foreign source of the active ingredient, doxycycline, which the
    United States sought to treat possible greater exposure to
    anthrax.
        In another capacity, I am the Ranking Member of the
    Homeland Security Committee, and we are actually in the process
    right now of drafting a report on our reliance on foreign
    pharmaceuticals in this country as a national security issue
    that we need to think about and the fact that in many cases it
    is 100 percent or 80 percent of critical drugs are manufactured
    off the shore of the United States.
        It is my understanding that China is currently the world's
    largest producer of active pharmaceutical ingredients, known as
    APIs, which we rely on to make drugs, including those that
    would treat a biological weapon attack or a pandemic, as you
    mentioned, Dr. O'Toole.
        My question to the panel is, to what extent is the United
    States reliant on foreign services for key drug products and
    medical supplies such as syringes and needles and other
    critical medical supplies that we would need to respond to a
    biological attack today? What is your assessment of that? Dr.
    O'Toole, if you want to start.
        Dr. O'Toole. We are critically dependent on China for a lot
    of drugs, and we have been shipping our manufacturing capacity
    to Asia for over a decade now. There is not a CEO [Chief
    Executive Officer] of a major pharma company who has not been
    recruited by China to build facilities there.
        You know, biology is not part of the DNA of the national
    security community in this country. We have not been paying
    attention to biology as a national security asset or as a
    possible threat, and that has to change.
        The fragility of our supply chain in terms of drugs is a
    real problem. I would say that we have begun exploring the
    possibility of using synthetic biology to make these active
    pharmaceutical ingredients, at least some of them, which I
    think deserves serious consideration. If there were a natural
    pandemic in which the entire world needed drugs, I am sure
    China, as we would, is going to take care of their own people
    first. We do not have the surge capacity we need even to
    produce enough of a very common, well used medicine like
    doxycycline in time to deal with an epidemic.
        It was also said after H1N1 that if we actually had been
    able to vaccinate the entire population of the United States
    with the flu vaccine that we eventually got against H1N1,
    though it was late for the epidemic, it would have taken 4
    years' worth of needles to do that. I mean, we have very
    insecure supply chains for some of the most critical elements
    of what would be required medically.
        Senator Peters. Thank you.
        Any other panelists like to join in, please?
        Dr. Gerberding. I will just add that I think our medical
    supply chain is vulnerable even under everyday circumstances.
    Of course, in the context of a global health threat, we would
    be severely challenged for not just countermeasures but for all
    kinds of medical products.
        One area that particularly concerns me is the area of
    antibiotics because we know we are facing antimicrobial drug
    resistance on an accelerating scale. CDC just published its
    update last week outlining the severity of that threat, and we
    do not have a robust supply of antibiotics today.
        One of the ways that we do invest to support that potential
    situation is through the Strategic National Stockpile, which is
    a very important U.S. asset, and I think it needs to be
    reexamined in light of the now known realities of market
    failures and the shortages of the durable goods that we are
    going to need for any significant threat.
        Senator Peters. I think it is important when you said we
    have some challenges right now because we see drug shortages
    across the board of many drugs that are simply not available,
    and it forces practitioners to move to a different drug that
    tends to be a whole lot more expensive, but it may not be any
    more effective clinically. Antibiotics as well. I understand we
    have critical shortages in antibiotics today without a
    biological crisis. You can imagine under a biological crisis,
    it would be catastrophic. It is something that we should be
    focusing on immediately.
        Dr. Inglesby, would you like to add?
        Dr. Inglesby. Yes. I would just add that I completely agree
    with what you have just been saying, and I do think that we
    treat medicines too much like commodities that can be sourced
    for the lowest price somewhere in the world. But if we think
    about medicines we would need in a crisis when every part of
    the world would be looking for them at the same time, there
    should be at least a strategic examination of the kinds of
    things that we must have, and we should consider how we could
    bring some of those medicines back to the United States.
    Obviously, that cannot be done for all medicines. We are a very
    connected world, but there are some products that are important
    enough for national security, for public health crisis that we
    should be thinking about making them here.
        Senator Peters. Thank you.
        Senator Ernst. Senator Hawley?
        Senator Hawley. Thank you, Madam Chair.
        Dr. O'Toole, let me come back to something you said just a
    moment ago, that China wants to own the biorevolution I think
    you said. What steps do you see China taking to succeed in that
    endeavor?
        Dr. O'Toole. First of all, China has a very detailed 5-year
    plan, and biotechnology is in that plan in many different ways.
        First of all, their goal is to make biotechnology 5 percent
    of their GDP by 2020. They have changed regulations for their
    own FDA [Food and Drug Administration] to be more like ours so
    that they can more easily market to the world. They have
    created a talent pipeline that incentivizes their own students
    to go into the life sciences and to bioengineering. They have
    at least 20 different programs, according to the House
    Oversight Committee, intended to bring scientific talent from
    the rest of the world, mostly the United States, back to China
    using very attractive incentives to bring even very senior
    American scientists back to do research in China.
        As I said, they have enticed a lot of pharma companies both
    using incentives, as well as doing a lot of, I will call it,
    confiscation of IP [intellectual property] once they are over
    and operating in China.
        They have changed their financial regulations to benefit
    Chinese biotech companies.
        I think this is important to understand because they have
    such a long-term well thought-out plan. They are building
    infrastructure in the form of whole universities, incubators,
    bio-office parks, primate research facilities, high containment
    labs very deliberately in order to give themselves the
    capability of basically being the major biopharma power of the
    world. But they are not just aiming at biopharma.
        We did an examination of their capabilities in synthetic
    biology. If you map synthetic biology and the different pieces
    of science and technology that you need to do this to make
    organisms into manufacturing plants, you will see that the
    United States is all over the map. We have all kinds of
    creative companies who are working in all aspects of synthetic
    biology. If you compare that to China, what they are doing is
    building from the bottom up, from the fundamental
    infrastructure up to the more creative parts, and they are
    doing it at scale. We have nothing like this. This is something
    that I know DOD is getting interested in at this point. We
    ought to encourage that. We ought to take on synthetic biology
    as a national security priority in view.
        Senator Hawley. What other defensive measures would you
    suggest? Or maybe ``defensive'' is the wrong word. Maybe
    ``proactive'' is better. But what measures from a policy
    perspective would you suggest and recommend that this country
    take in order to not only prevent China from owning the
    biorevolution but making sure that we do, for lack of a better
    expression?
        Dr. O'Toole. Well, this has been called the Sputnik moment
    in terms of the biorevolution. What we did back then worked
    pretty well. I think taking a look at the National Defense
    Education Act and really revving up science and technology
    education in this country--I would love to do it pre-
    kindergarten through whatever. But I think we need talent fast.
    I would look at incentives to encourage young people to go into
    biology and biotech, but I would also look at how we get them
    into government because government really needs more technical
    expertise than it has easy access to right now. These people
    have a lot of options in terms of jobs. That is where I would
    start, is the talent pipeline.
        I also would consider making one of the national labs
    responsible for advancing some of these foundational
    biotechnologies, particularly the analytical part, the big data
    part of biology, so that we can strengthen the foundational
    technologies of genomics, and AI [artificial intelligence]
    applied to biology is going to be a very big deal. I could go
    on, but I do not want to take the whole hearing.
        Senator Hawley. That is very helpful. Thank you very much.
        Thank you, Madam Chair.
        Senator Ernst. Yes. Thank you.
        This is a very helpful discussion today. I really do
    appreciate it.
        I know there are a number of other committees that might
    have jurisdiction over these types of topics, whether it is
    USDA, whether it is Homeland Security. Here in the Senate Armed
    Services Committee, we have not had a hearing on this topic for
    20 years. Yes, pretty shocking. It is time. It is time to do
    this. Again, thank you for doing that.
        The reason I get very excited about this and so interested
    in it is the fact that every time I do meet with different
    agriculture commodity groups, in particular our Iowa pork
    producers, when I am back in Iowa, one of the key concerns that
    they have is actually how do we secure and protect our
    livestock against biological threats.
        My question to all of you is, with agriculture being such a
    significant part of not only our Iowa economy, but also the
    American heartland, how significant of a threat is there, and
    what can we do to mitigate that?
        Dr. Gerberding. I will start by just acknowledging that
    mother nature is a really good terrorist. China today is
    experiencing a dreadful outbreak of swine fever that has
    probably the caused the death or culling of at least 50 percent
    of their entire population of pork, which is the major source
    of protein for people in China. This is a major socioeconomic
    threat to the stability of the state of China today, and that
    is mother nature.
        To my knowledge, every state that has engaged in offensive
    weapons development has also looked not just at human terrorism
    or human biologic, but also animal and agricultural biologic
    capabilities. We have to assume that that is still an ongoing
    issue in state-based efforts, not to mention what might be
    cooked up in the garage of a terrorist somewhere along the way.
    These are easy things to do. We have very little surveillance
    and very little capacity in most of the vulnerable places in
    the world to do anything about it. I think it is a huge and
    unrecognized, under-mitigated threat.
        Senator Ernst. Thank you.
        Yes, Dr. Inglesby.
        Dr. Inglesby. Yes. I completely agree with Dr. Gerberding.
    I would say that the first alarming statistic is that we spend
    probably about 100 times less on agricultural threats than we
    do on human threats. I think there are many reasons for this,
    but one of them includes a kind of a reluctance in the U.S.
    Government to talk about this threat until quite recently. I
    think if you go back 5 years or 10 years in the interagency
    discussions around bioterrorism, USDA was not a strong player
    because USDA has a mission of promoting the food industry, and
    I think people felt at the time that that was kind of giving
    mixed messages and concerns and fears. I think that has
    changed, and I have been impressed with how USDA has been
    stepping out and really kind of being a serious player in the
    interagency around the National Biodefense Strategy
    development. I think programs are stronger than they were.
        But still they are small compared to the size of U.S.
    agriculture, the crops and the herds and the animals around the
    country. As Dr. Gerberding said, there are many natural threats
    that in terms of terrorism, simply moving a natural threat from
    one place in the world with some simple sample transfer into
    U.S. herds or crops would be relatively straightforward to do.
    There is a long list of diseases both for animals and for crops
    that could cause a terrible impact in our country.
        In general, I think there needs to be greater emphasis,
    greater funding for this problem. There is not an integrated
    risk assessment list for USDA. There are programs that focus on
    different diseases, but we could raise the entire enterprise by
    having a more organized list of what the biggest problems are:
    a stronger national veterinary stockpile, better surveillance
    programs for crops and wildlife. There are a number of concrete
    things that can be done, but building on recent successes in
    USDA--I think they are showing that they can really step up
    their programs, but they just need the support of the Congress.
        Senator Ernst. Yes. Dr. O'Toole, do you have a comment?
        Dr. O'Toole. I agree this is a big threat. The same forces
    that are driving natural epidemics are driving epidemics among
    animals. What is happening with African swine fever moving
    around the world is certainly going to happen again and again.
        What we need to do is the same. We really, really, as a
    matter of national security, need to get better at managing
    epidemics. We keep making the same mistakes again and again and
    again. The technologies to change this either exist or are
    within reach. For animals, we need rapid, cheap, easily
    manufactured pen-side diagnostics, as they are called, to
    figure out if pig A is sick and pig B is not, as opposed to
    killing all the pigs within a certain radius of an animal who
    is diseased. We can get those kinds of options if we are
    willing to invest in them.
        In agriculture, one of the advantages is you have a
    commercial push for these kinds of technologies if the U.S.
    were to lead some of the basic research that you do not have as
    easily in human outbreaks where the opportunity costs for the
    drug companies are so wildly out of sync that they are not
    going to develop new antibiotics, et cetera, as we have seen.
    But we can do a much better job at managing animal disease then
    we are doing now.
        Senator Ernst. My message back to Iowa is we can get there.
    We just need to step it up. Is that right?
        Dr. Inglesby. Yes.
        Senator Ernst. Okay. Thank you very much.
        Ranking Member Peters?
        Senator Peters. Thank you, Madam Chair.
        I think I will continue the line of thought by Chairman
    Ernst, protecting the agricultural industry. Michigan is also a
    big agricultural State, in fact, the second most diverse
    agricultural State next to California, with all sorts of crops.
    As Ranking on Homeland Security, I authored a bill to increase
    our agricultural inspectors at the border, which is critically
    important to protect that industry, as well as public health.
    We are understaffed when it comes to agricultural inspectors.
    We will hopefully change that if the House acts on the bill
    that we just passed out of the Senate. Not only human
    inspectors but probably the most sophisticated tool you can
    use, which are canine teams. Sophisticated noses of dogs is
    pretty amazing as to what they can pick as things are crossing
    the border.
        My question is--and especially, Dr. Inglesby, you are
    talking about how we need to do more--I will get the assessment
    of the panel. What sort of coordination is going on between
    USDA, the Department of Defense, the CBP [U.S. Customs and
    Border Patrol], or Homeland Security folks? We have to be able
    to identify where some of these outbreaks are around the world,
    alert folks here who are on the border protecting us. We have
    got to have a real coordinated system. What is your assessment
    of how coordinated that is? Do we need to do a lot more, and
    what would be your advice? Whoever would like to start. I would
    love to have all your thoughts.
        Dr. O'Toole. Well, I will start.
        I spent 5 years in Homeland Security. People do try to
    coordinate, but they do not have the tools they need to make
    this a very reassuring process.
        Without the technology--dogs are great. Love dogs, have
    one. It is really hard to----
        Senator Peters. We need more than dogs you are saying.
        [Laughter.]
        Dr. O'Toole. We really need more than dogs.
        Senator Peters. But they are great.
        Dr. O'Toole. They are good for some things. It is very
    difficult to quantitate how good they are or whether the dog is
    having a bad day. They are great as a first line of defense.
    They are not very reassuring as the line of defense.
        If you go to a port and you see what CBP is faced with day
    after day in terms of trying to figure out whether exotic pests
    are coming in, a big threat to agriculture, for example, they
    actually disassemble trucks, loaded trucks, and go through them
    box by box, packing straw by packing straw to find bugs and
    then compare them to the charts on the wall, what bug is this.
    We need more technology to do this more effectively. That is
    all there is to it.
        I think people are trying to coordinate amongst the
    agencies. I do not think they have the tools that they want. I
    agree with Dr. Inglesby. Agriculture has been late to the
    table. They need a much bigger research budget. I do not think
    you can do much about that from this committee. But again, we
    are under-investing in these areas in terms of R&D [research
    and development] and the translational science that has to come
    out of it. These things now are in the arena of national
    security.
        Senator Peters. Does anybody else want to add?
        Dr. Inglesby. Yes. I would just add just a couple of
    sentences.
        I would say one very encouraging thing was when the
    National Biodefense Strategy was getting developed in the lead
    up to 2018 fall, there were four agencies that were co-
    conspirators or co-leads on the effort, and USDA was one of
    them, alongside DHS [U.S. Department of Homeland Security],
    HHS, and the Department of Defense. That was surprising to many
    people in the field because USDA had been kind invisible
    before. That was a sign of them really being either pulled or
    stepping up into the interagency. They are part of an
    integrated lab network that looks at CBRN [chemical,
    biological, radiological, and nuclear] threats alongside HHS
    and EPA [U.S. Environmental Protection Agency] laboratories.
    There is some kind of interaction there. They definitely do
    engage internationally with the Food and Agriculture
    Organization, which is the big organization around food safety
    in the world. I think there is some interaction, but I
    completely agree with Dr. O'Toole that they are on the rise,
    but they are still kind of starting from a lower position in
    terms of research and budget.
        Dr. Gerberding. I would just add a very small but important
    perspective, and that is the vast majority of the new or
    reemerging infectious diseases that are being evolved naturally
    are zoonotic diseases, meaning they arise from animals. The
    criticality of the integration between USDA and the CDC for
    infectious disease surveillance and adding into that the EPA
    because some of these diseases also involve the ecosystem--we
    really need a one-health approach to understanding emergence.
    Again, the technologies are sorely lacking because there is not
    an investment in that kind of not just interagency but
    interdisciplinary research and tech translation.
        Senator Peters. It is clear we need a whole-of-government
    approach here, and we are far from actually doing that now. I
    think that is certainly a big takeaway from that exchange from
    you, which I appreciate.
        I was just at the Detroit Metropolitan Airport seeing a
    demonstration of those dogs and others.
        But the one thing that was particularly concerning to me is
    the amount of actual biological material and viruses and others
    that are coming across. The people who are researchers--they
    are bringing all sorts of agents in, which they should not. In
    fact, I understand half of all the biological material that is
    stopped at the border is at Detroit Metropolitan Airport. I
    said is it because it is Detroit or because you are really good
    at it. The answer was probably a little bit of both. But it is
    concerning as to what are we not stopping. For whatever we
    stop, I am sure there is a lot that is getting through, which
    is why this is so critical that we put that together.
        If I may, I am a little over time, Madam Chair. If I may
    just ask another question.
        Dr. Gerberding, you mentioned the study, the Cycle of
    Crisis and Complacency. In your testimony here today as well,
    your oral testimony, you talked about where pandemics are
    occurring or where they start--the outbreaks are occurring
    around the world--they are usually places of great disorder, a
    lot of things happening there. The security issues are
    incredibly challenging where they come from. The Ebola outbreak
    in Congo is an example of that occurring in a place with
    regional conflict.
        In 2014, in the Ebola outbreak, the United States was able
    to deploy a real massive, kind of a heavy lift of folks to help
    deal with that situation. Three thousand combat engineers,
    mobile hospitals, and marshaled a combined team of medical
    professionals from the Army, the Navy, the Public Health
    Service. Actually the Michigan National Guard was engaged in
    Liberia, our partnership state there. We had a number of our
    guards people there that forward deployed as well.
        My question to you is to what extent do you think the DOD,
    when responding to these issues, really has to be doing more
    than just providing medical services? They are going actually
    have to stabilize a region. That is a broader mission than we
    normally think about when we are dealing with a potential
    outbreak of a pandemic, and yet the consequences of not
    containing that pandemic can be catastrophic. How do we square
    all that, and how should we think about deploying DOD assets in
    these kinds of emergencies?
        Dr. Gerberding. I think it is a very complicated set of
    issues. In the case that you cited in Liberia, our military was
    welcomed into the environment, and the mission there was
    primarily logistics, building infrastructure to support the
    relief efforts that were ongoing, hospitals, infrastructure, et
    cetera. Our Department of Defense is accustomed to providing
    that kind of humanitarian logistic support in all sorts of
    natural disasters, et cetera.
        But we were not there to provide security. Generally, we
    would like to think that the UN [United Nations] security
    forces or the local governments would have that responsibility,
    but as we have seen in the DRC, that is not always the case nor
    is it always successful. I think that challenges the role of
    the Defense Department in providing the security when the
    threat in one region could extend to be much broader or a
    threat to the United States. I think that is an area where we
    need a lot of strategic policy work on an ongoing basis.
        The other side of the coin and part of the reason why the
    commission report recommends the development of this ready
    corps is because we need to bring a certain kind of technical
    expertise, which is not the military's forte, but the
    surveillance, the epidemiology, the tech transfer, the
    diagnostics, et cetera, et cetera, that we need deployable
    troops who are trained to be able to go in and instigate those
    capabilities in environments that are not intrinsically secure.
    We do not have that capability right now. That is why it has
    been so challenging for the CDC, for example, to be in the DRC
    because we do not have the security context and we do not
    really have that kind of deployable, well trained, well
    exercised unit to serve in that sort of environment. It is an
    unmet need and one that I hope we would really put a higher
    priority on addressing going forward.
        Senator Peters. Thank you.
        Dr. Inglesby. I would maybe just add a comment.
        Senator Peters. Yes, please.
        Dr. Inglesby. In the West Africa Ebola response in 2014-
    2015, in my view and I think the view of many, it really was a
    threshold moment when the President decided that the Department
    of Defense would become fully engaged in the operations around
    response. DOD did not send doctors and nurses, but they sent
    heavy lift. They sent their ship. They started building things.
    They already had laboratories there that were working on
    diagnostics. That was a real threshold moment.
        I think in the aftermath of that, as people have reviewed
    the DOD experience in West Africa, there still is a tension
    within the Department of Defense about the extent to which the
    Department of Defense should be involved in foreign operations
    around infectious disease crises. In my view, they are
    indispensable in terms of operations. If you really want
    something to be done by the U.S. Government, DOD has by far the
    most operational capacity, and there are going to be moments to
    do that. But I understand that in DOD leadership in the command
    leadership, that there is reluctance to have doctors and
    nurses, in particular, involved because of the way that it will
    affect overall operations.
        I think it is an open issue. I would urge the DOD to be
    involved in those kinds of operations, but I do not believe it
    is resolved within the strategy.
        The second thing I would say, just to echo Dr. Gerberding,
    is that in the current DRC Ebola response, the CDC has been
    indispensable in the last 20 Ebola responses since Ebola was
    discovered. In this response, they were held back by the U.S.
    Government for safety and security reasons because we had no
    way for the U.S. Government to determine that there was no safe
    way to have them in the field for a long period of time. That
    is beginning to change.
        But it does show that we will need in the future, since
    more and more outbreaks are happening in disordered, broken
    places in the world where things could spiral, get a foothold
    and then create chaos in the region--we are going to need, as
    Dr. Gerberding said, ways to operate in unsafe environments,
    ways to have our scientists and experts and public health
    officials be in places where outbreaks are out of control even
    if they are unsafe. I do think it is an important issue that we
    have not really resolved.
        Senator Peters. Probably new specialized units that are
    specifically trained for that.
        Dr. Inglesby. Yes. Units that are part of that that are on
    the DOD side, units on the CDC side, scientific side. I think
    they will need to be able to work together in ways we have not
    sorted out.
        Senator Peters. Thank you.
        Dr. O'Toole. May I comment on that?
        Senator Peters. Yes.
        Dr. O'Toole. I am all for training the special units, but I
    think the situation on the ground is going to outrun even the
    U.S. Government's ability to take care of it unless we have
    better technologies. We are much better off trying to figure
    out how we could make vaccines on demand and then distributing
    those than we are sending thousands of members of the armed
    services just to quell disorder. We have to get a strategic
    approach to epidemics that has got to look very different from
    what we are doing now. I think technology is the way through.
    Because of the biorevolution, there are possibilities out there
    that we could make good on if we invested in them.
        Senator Ernst. Thank you, Dr. O'Toole.
        I want to continue on a little bit with some of that
    technology. You had mentioned that the integration of
    artificial intelligence is important in staying ahead of
    various biothreats. If we can just discuss that briefly, I
    think that would be very helpful for me. Can you elaborate on
    how this type of technology would impact both the potential
    offensive and defensive applications with respect to biotech?
        Dr. O'Toole. Artificial intelligence of different kinds,
    machine learning, deep neural networks, and so forth, is
    already being used, for example, in drug discovery to hasten
    drug discovery. It is being used in medical imaging and in
    digital health in many different ways. But it is going to have,
    I think, the greatest near-term impact in biology on these
    foundational technologies, on genomics and synthetic biology in
    particular.
        If you think of genomics as you are trying read a code of a
    single genome--and today we are trying to understand what a
    particular gene does by comparing it to many genomes and trying
    to figure out this person is sick because that gene there is
    missing, to take a simple case. In that case, the bigger your
    library, the more genomes you have sequenced and put into a
    library that keeps things accurate and easy to access, you are
    advantaged. What AI is going to do is not only make it faster
    to sequence genomes, but they will be done so more accurately.
    Google has already done this and shown one way to do it, mostly
    using machine vision.
        What you then want to know is you want to understand how to
    read and write the genome once it is sequenced. What AI allows
    you to do is intelligently go through all of these
    multitudinous possibilities much faster and more accurately.
    Then you can iterate on it.
        It is going to improve sequencing. It is going to improve
    DNA synthesis, and it is going to improve DNA editing. There
    are already basic science experiments going on in all those
    fields.
        China, for example, has of course a philosophy that the
    state and the private sector are one and the same. The military
    and the private sector are one and the same. They have combined
    their big Internet giants, Alibaba, Tencent, and so forth with
    their biotech companies. Alibaba is investing in biotech.
    Tencent is helping BGI, Beijing Genomics, Inc., with their
    sequencing problems. They have recognized and are
    industrializing this combination of AI and biotech. It is
    mostly going to be beneficial. It is going to help us get new
    medicines faster. It is going to help us understand toxicity
    earlier. It is going to create whole new realms of products
    that we have not imagined yet. But they, as I said, are
    institutionalizing it. We are experimenting with it.
        Senator Ernst. I appreciate that. Again, we need to step up
    in this area and find those solutions.
        Your estimation--and I am drawing from that that there is a
    lot of work that we need to do. But how well postured is the
    Department of Defense in leveraging AI in a biodefense
    strategy?
        Dr. O'Toole. I do not think they have thought about it yet.
        Senator Ernst. I would probably agree with that assessment.
        Anybody else care to comment on that?
        [No response.]
        Senator Ernst. Dr. Gerberding, if we could go back a little
    bit. We were just talking about the collaboration between
    different governmental agencies. The Health Security Commission
    report released today by CSIS recommends restoring health
    security leadership at the White House National Security
    Council. When was this position established? Then why was it
    eliminated?
        Dr. Gerberding. In my experience in the context of some of
    the most difficult and threatening infectious disease
    outbreaks, inevitably someone is pulled to be the czar of the
    occasion for that particular situation. But in 2016, the White
    House did appoint a senior White House official reporting
    through the National Security Council to be responsible for a
    directorate that was charged with the preparedness and response
    to biologic threats. That directorate was established. It began
    its work, and then in 2017 it was disbanded. I do not know why
    it was disbanded. I think there were lots of changes. The
    administration changed and so forth. But I think the mentality
    often has been that these are important during a crisis, but
    the need for them dissipates once the acuity of the crisis has
    subsided.
        Senator Ernst. But the recommendation would be that it
    needs to be a consistent, stable position within the National
    Security Council.
        Dr. Gerberding. It has been an essential role for cross-
    government collaboration in every single infectious disease
    situation I have ever observed.
        Senator Ernst. Do you believe then having that position in
    place, that person would be able to assist maybe in
    orchestrating the breakdown of various silos that exist between
    agencies?
        Dr. Gerberding. That would be a primary function, and that
    applies both to the planning and strategy that we have been
    talking about is missing across a number of our agencies, but
    also in the actual operations and in the aftermath. It is a
    continuous cycle, and it needs that constant strategic,
    iterative improvement over long arcs of time.
        Senator Ernst. Okay. We are going to go ahead. Senator
    Peters will have just a couple more questions.
        Senator Peters. Thank you, Madam Chairman.
        Dr. Gerberding, this was in your report as well. As you
    know, the Department has used the Cooperative Threat Reduction
    (CTR) program, which is also known as the Nunn-Lugar program,
    for the past 20 years to help us reduce some of the danger of
    biothreats in the United States. The program started out in the
    former Soviet Union to secure bioweapons stockpiles in their
    program, but we have continued to use that program. Your study
    specifically calls out this program as something that should be
    protected and sustained. Dr. Inglesby, I know you were involved
    in that as well.
        My question to you is what should the CTR program focus on
    in the future with respect to securing biological threats that
    could harm the United States in your estimation. If both of you
    could answer that and, Dr. O'Toole, if you want to jump in too.
        Dr. Gerberding. Yes. I will start.
        I had an introduction to this capability a number of years
    ago when there was an outbreak of plague in one of the
    countries that was formerly a part of the USSR [Union of Soviet
    Socialist Republics]. The question was, the plague that we were
    observing in animals was actually a sign that there was some
    offensive weapon development and deploying going on, and that
    resulted in an investigation comparing biologic fingerprints
    and so on and so forth. It revealed to me how important this
    effort was to provide resources and support for scientists to
    redeploy their technical capabilities in constructive
    directions and so forth. Since that time, this has come up in a
    number of other areas of the world.
        My own opinion is this is an extremely important
    methodology for repurposing scientific know-how and acumen, but
    also harnessing that expertise in ways that truly can hopefully
    transition into more constructive biotechnology solutions. I
    see it as a high priority for continuation, and I would look
    forward to Tom's view because I know we have had this
    conversation before.
        Dr. Inglesby. Yes. I also think it is quite a valuable
    program, and I think it is a place in the government that helps
    other labs and research facilities in the world develop
    biosafety practices and biosecurity practices that increase the
    chance that pathogens will stay safe in their refrigerators and
    not walk out with people or not be susceptible to theft or
    diversion.
        I think they also do a lot of important training programs
    to try and train trainers in different parts of the world. I
    know that CTR BTRP [Biological Threat Reduction Program], the
    bioprogram in CTR, recently had a training program in North
    Africa which trained biosafety and biosecurity leaders from a
    variety of North African countries in the context of violent
    extremist organizations trying to kind of think about the
    overlap between terrorism and potential diversion of samples. I
    think that is the kind of thing that they do very well. I think
    they are in nearly 30 countries, 29 countries in the world, and
    are doing things that other parts of the government are not
    doing.
        They also are trying to help build surveillance systems. I
    mean, there are many other agencies, especially CDC, that do a
    lot of very critical disease surveillance. I think with their
    relationships that they have established in laboratories, they
    can be helpful to that larger mission.
        Senator Peters. Dr. O'Toole, my last question to you, just
    to pick up on what you were you talking about with the advances
    in synthetic biology and CRISPR, all these new technologies
    that are going to change the world dramatically. It is an
    exciting time to live, but it is also a scary time to live at
    the same time.
        My question to you is that whenever you are dealing with
    advanced research in biology, it can often raise a whole host
    of moral and ethical issues that need to be addressed. Given
    the value system that we have in this country, we want to
    adhere to that at every step possible. However, other countries
    may have a different set of moral and ethical principles. How
    do you see those different principles in terms of biological
    research? How do you think about that? Is that a concern for
    you? As a committee, how should we be thinking about countries
    that are not going to be constrained in the same way we are
    likely to be constrained in this country when it comes to
    biomedical research?
        Dr. O'Toole. This is an area of profound questions that I
    think have to be approached very carefully and very seriously.
    We will be disadvantaged compared to China in some areas of
    biology, stem cells for example, because they are moving
    forward faster than we are. In the end, they may make more
    mistakes and we may get to the happy place sooner. As a
    physician, I believe very strongly in doing everything we can
    to avoid doing harm. Science is very empirical. Sometimes you
    make mistakes and you have to pull back and think again. I
    think this is going to be a knotty problem that deserves very
    sustained, high-level attention.
        When we started the human genome project in this country,
    we built in the funding for the project money to pay for
    research in ethics. I would recommend that we do the same thing
    again for synthetic biology, for gene engineering, and so
    forth. What it did was it laid the groundwork for a national
    dialogue, which I think was extremely constructive. All of the
    anxiety and true fear that popped up when we first started
    doing recombinant DNA back in the 1970s has proved not to have
    led to a terrible tragedy I think partly because we moved very
    thoughtfully forward. We have to create the foundation and the
    infrastructure for doing that again for these sciences.
        I would say about China, though, that they are in a
    terrible place vis-a-vis the health of their population. The
    reason they are moving forward so aggressively is that they are
    desperate for progress. When you look at the opinions of the
    Chinese people, they are much more acceptable of risk than I
    think Americans are in this realm. They are very interested in
    new technologies that they think could help cure disease,
    change birth defects, et cetera, et cetera. I do not read the
    gene-edited baby episode as China being negligent so much as I
    think it is a more nuanced view of that particular situation is
    warranted on our part. They have terrible problems that they
    are trying to fix, and that is part of their appetite for risk.
        Senator Peters. Thank you.
        Dr. Inglesby?
        Dr. Inglesby. Yes. I would just certainly agree. I would
    just add that the U.S. has had the opportunity to set standards
    in the world around science for a generation, and often when
    the U.S., especially in the world of science, the NIH [U.S.
    National Institute of Health], in partnership with other
    agencies, has taken positions or the recombinant DNA conference
    back in the 1970s which helped set standards for how to manage
    recombinant DNA science--I think those things do have a chance
    of taking hold elsewhere in the world. The more that we can
    kind of promulgate and seek partnerships around this, I think
    it is real. I think it can help.
        I am particularly worried about a very small realm of
    science, which has emerged in the last few years, which is
    science intending to create very pathogenic strains of
    pathogens. I think we have not taken the position we took in
    other kinds of technologies like gene editing or recombinant
    DNA science. We have actually gone in the other direction. We
    have been, I think, way in front of our headlights, and other
    countries are observing how we are operating and how we are
    funding that science. I think there are things that we could do
    in our own governance of science which would be, I think, a
    little bit more responsible. But generally speaking, I think
    the U.S. is able to help set some standards that other people
    pay attention to.
        I know China, just to speak about China--there was a
    meeting this summer where a number of Chinese scientists came
    over to talk about the gene-edited baby experience. I think
    there are many leading scientists in China who were shocked and
    appalled about how that all happened. I think they certainly
    have to think about their disease risks in their population,
    but they are also worried about how scientists kind of got out
    in front of their scientific establishment. I do not think it
    is a homogenous national reaction to gene editing. I think
    there are proponents of it, and there are people who are
    worried about it as well, even in China.
        Senator Peters. Thank you. I appreciate it.
        Senator Ernst. I am going to wrap up the hearing with just
    a quick question, and all of you can participate in this. I am
    going to give you the big four that we have. Near peer
    adversaries--but what is the current estimate of biological
    warfare capabilities? So, for example, the range of delivery,
    extent of biological weapons available, amount of biological
    weapons, so on and so forth. Low, moderate, or high for North
    Korea. What would your assessment be of North Korea and their
    biological capabilities? It is a fun little exercise. Very
    enlightening.
        Dr. O'Toole. I think every country in the world has the
    capability of delivering a devastating biological weapon, North
    Korea included. I think they are probably more intent on it. It
    is very difficult to collect intel out of North Korea. There
    are indications that they have a BW [biological warfare]
    program. Beyond that, we would have to be in a classified
    space.
        Senator Ernst. Absolutely.
        Dr. Gerberding. I would just say it behooves us to assume
    they do, whether we have evidence to back that up or not. I
    think it is more likely than not.
        But I would also just like to say one more time the best
    terrorist of all is mother nature.
        Senator Ernst. Yes, Dr. O'Toole.
        Dr. O'Toole. That gets said a lot, and I think it is no
    longer true. I think we have to understand that the capacity to
    build new, very powerful, very, for want of a better word,
    sneaky biological weapons has been unleashed, and it is widely
    accessible. We have got to start thinking about this in a
    national security context.
        Senator Ernst. Can we say that is probably true then of
    North Korea, Russia, China, Iran?
        Dr. O'Toole. Yes.
        Senator Ernst. Dr. Inglesby?
        Dr. Inglesby. I agree that any country with any kind of
    industrial capability, any kind of basic science program, which
    is almost all countries on the planet, if they chose to make
    biological weapons, they would succeed. There are not any
    technical barriers that would prevent a country from doing
    that.
        I think what is really useful at the moment is that we have
    a Biological Weapons Convention, which creates a very, very
    strong taboo against it, an international pariah status if you
    are caught making biological weapons. It is not a perfect
    treaty, and there are obviously countries that have cheated on
    it. But it is a helpful norm given that any country could
    certainly step up and develop and use biological weapons if
    they chose.
        Senator Ernst. Very good.
        On that happy note, I think we will go ahead and wrap up
    this hearing this afternoon. I do appreciate the input that has
    come from our panel of experts in this topic. It underscores
    the fact that we as the United States Government, as DOD, also
    need to truly step up what we are doing on biological warfare
    preparedness, as well as making sure that we are breaking down
    those silos that exist between DOD and maybe all of the other
    agencies that are working in these areas as well.
        With that, I want to thank you once again for joining us
    today.
        This will conclude our Emerging Threats and Capabilities
    hearing.
        [Whereupon, at 4:17 p.m., the subcommittee adjourned.]

                               APPENDIX A

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